Pancreatic carcinoma – Trials in Disease

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Clinical Trials for Pancreatic Carcinoma: Current Treatment Options and Research Studies

There are currently 48 ongoing clinical trials investigating new treatments and approaches for pancreatic carcinoma. These studies are testing various combinations of chemotherapy, immunotherapy, surgical techniques, and targeted therapies across multiple countries. This comprehensive guide provides detailed information about these trials, including eligibility criteria, treatment approaches, and locations where patients can participate. (Also known as: Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Adenocarcinoma)

Clinical trial locations

A Study of FOLFIRINOX Drug Combination Before Surgery Compared to Immediate Surgery in Patients with Resectable Pancreatic Head Cancer

This study evaluates whether giving chemotherapy before surgery can improve survival in patients with pancreatic head cancer that can be surgically removed. The research compares two treatment approaches: one group receives FOLFIRINOX chemotherapy before surgery followed by standard treatment, while the other group receives immediate surgery followed by chemotherapy.

Main inclusion criteria: Patients must be at least 18 years old and healthy enough for major surgery. They need confirmed pancreatic head cancer that is resectable (removable by surgery), classified as T1-3, Nx, M0, meaning the cancer is localized without distant spread. Both men and women can participate.

Main exclusion criteria: Patients under 18 or over 75 years, those with metastatic disease (cancer spread to other body parts), previous chemotherapy or radiation for pancreatic cancer, other active cancers, severe heart conditions, liver or kidney problems, pregnancy or breastfeeding, or those unable to provide informed consent cannot participate.

Trial focus: The study aims to determine if neoadjuvant chemotherapy (treatment before surgery) can reduce early deaths and extend overall survival compared to immediate surgery. The FOLFIRINOX regimen includes fluorouracil, irinotecan, oxaliplatin, and calcium folinate, administered through intravenous infusion. Treatment may last up to six months.

Investigational drugs: FOLFIRINOX is a combination chemotherapy containing folinic acid, fluorouracil, irinotecan, and oxaliplatin. It works before surgery to shrink tumors, making surgical removal more effective and potentially improving survival chances.

Evaluation of Hydrocortisone, Octreotide, and Teres Ligament Patch Combination to Prevent Complications After Pancreatoduodenectomy in Patients with Pancreatic Head Cancer or IPMN

This trial investigates whether a combined treatment called the HOP bundle can reduce major complications after pancreatoduodenectomy surgery in patients with pancreatic head cancer or intraductal papillary mucinous neoplasms (IPMN). The research focuses on patients with small pancreatic ducts (3mm or less), who face increased risk of post-surgical complications.

Main inclusion criteria: Patients must be over 18 years old, have planned elective pancreatoduodenectomy for pancreatic head cancer or IPMN, and have a pancreatic duct diameter of 3mm or less on preoperative imaging. The surgery can be either minimally invasive or open procedure.

Main exclusion criteria: Patients with allergies to study medications (hydrocortisone, octreotide, or teres patch), current or recent infections, uncontrolled diabetes, pregnancy or breastfeeding, severe liver or kidney disease, conflicting medication use, participation in other trials within 30 days, chronic pancreatitis history, or any condition making participation unsafe cannot join.

Trial focus: The HOP bundle combines three components: hydrocortisone (reduces inflammation), octreotide (reduces pancreatic secretions), and teres ligament patch (reinforces surgical connections). Participants are randomly assigned to receive either HOP bundle treatment or standard care, with monitoring for complications including pancreatic fistula, delayed gastric emptying, and post-surgery bleeding.

Investigational drugs: Hydrocortisone reduces body inflammation, octreotide decreases pancreatic enzyme secretion, and the teres ligament patch reinforces surgical areas. Together, these treatments aim to prevent serious post-surgical complications in high-risk patients.

Study Comparing FOLFOX (Oxaliplatin, Fluorouracil, Calcium Folinate) to Gemcitabine for Patients with Metastatic Pancreatic Cancer Not Suitable for FOLFIRINOX

This study compares two chemotherapy treatments for patients with metastatic pancreatic cancer who cannot receive full-dose FOLFIRINOX. One group receives FOLFOX (combination of oxaliplatin, fluorouracil, and calcium folinate), while the other receives gemcitabine. The trial evaluates which treatment provides better outcomes for these patients.

Main inclusion criteria: Patients must have confirmed metastatic pancreatic adenocarcinoma, be 18-75 years old, have ECOG performance status 0-2 (able to perform daily activities with some assistance), received no prior chemotherapy for metastatic disease, have measurable disease, and adequate blood counts, liver, and kidney function.

Main exclusion criteria: Patients with other cancer types, previous FOLFIRINOX treatment, fitness for FOLFIRINOX, inability to follow study procedures, serious medical conditions, pregnancy or breastfeeding, concurrent participation in other trials, or allergies to study drugs cannot participate.

Trial focus: The study monitors participants over time to assess overall survival, disease response, and side effects. Both treatments are administered through intravenous infusion, with regular follow-up to evaluate effectiveness and safety in patients not suitable for more intensive chemotherapy.

Investigational drugs: FOLFOX combines oxaliplatin, fluorouracil, and calcium folinate to fight cancer by interfering with cancer cell DNA. Gemcitabine slows or stops cancer cell growth by disrupting DNA processes. The trial determines which treatment better controls disease in patients unable to tolerate more aggressive therapy.

Study Comparing Gemcitabine and Paclitaxel Albumin-Bound for Fragile Patients with Non-Resectable Pancreatic Cancer

This trial compares standard-dose gemcitabine against reduced-dose combination of gemcitabine and abraxane (paclitaxel albumin-bound) for patients with non-resectable pancreatic cancer who cannot tolerate full-dose chemotherapy. The study aims to find the most effective treatment for fragile patients.

Main inclusion criteria: Patients must be at least 18 years old, have mild or resolved side effects from previous chemotherapy, confirmed pancreatic adenocarcinoma that cannot be surgically removed, be unsuitable for full-dose combination chemotherapy but eligible for full-dose gemcitabine or reduced-dose combination therapy, have performance status of 2 or less, and adequate blood cell counts and organ function.

Main exclusion criteria: Previous different cancer (except certain skin or cervical cancers), serious heart problems, severe liver or kidney disease, pregnancy or breastfeeding, active infections requiring treatment, known allergies to study drugs, concurrent participation in other trials, or health conditions deemed unsafe by study doctors.

Trial focus: The study evaluates progression-free survival, overall survival, response rates, hospitalizations, and quality of life. Both treatments are given intravenously, with close monitoring of patients’ health and treatment tolerance throughout the study period until December 2026.

Investigational drugs: Gemcitabine slows or stops cancer cell growth. GemNab combines gemcitabine with another drug at reduced doses to determine if this modified approach is better tolerated and effective for fragile patients with non-resectable pancreatic cancer.

Study Comparing Gemcitabine and Paclitaxel with Drug Combination for Patients with Advanced Pancreatic Cancer

This study compares two treatment approaches for advanced pancreatic cancer: switching from FOLFIRINOX to gemcitabine and nab-paclitaxel versus continuing modified FOLFIRINOX. The trial evaluates which strategy provides better overall survival after initial FOLFIRINOX treatment.

Main inclusion criteria: Patients must provide informed consent, have adequate kidney function, normal blood clotting tests (unless on blood thinners), not have complete DPYD enzyme deficiency, use effective birth control, be at least 18 years old, have confirmed unresectable locally advanced or metastatic pancreatic adenocarcinoma, measurable disease, tumor sample for analysis, ECOG performance status 0-1 (or 0 if 70+), life expectancy over 3 months, and adequate blood counts and liver function.

Main exclusion criteria: Patients without advanced pancreatic cancer, outside specified age range, and vulnerable populations who cannot make informed decisions about participation are excluded.

Trial focus: After completing initial FOLFIRINOX treatment, patients are randomly assigned to continue FOLFIRINOX or switch to gemcitabine/nab-paclitaxel combination. The study measures overall survival, disease-free survival, and treatment side effects through regular monitoring and assessments.

Investigational drugs: Gemcitabine and nab-paclitaxel work by slowing cancer cell growth and interfering with cell division. Modified FOLFIRINOX combines multiple chemotherapy drugs attacking cancer cells through different mechanisms. The trial compares continued use of FOLFIRINOX against switching to gemcitabine/nab-paclitaxel.

Study of AZD9574 and Temozolomide for Patients with Advanced Solid Tumors, Including Breast, Ovarian, Pancreatic, and Prostate Cancers

This trial tests a new medication called AZD9574, both alone and combined with other anti-cancer treatments, in patients with advanced solid tumors including IDH-mutant glioma, HER2-negative breast cancer, ovarian cancer, prostate cancer, and pancreatic cancer with specific genetic mutations (BRCA1, BRCA2, PALB2, RAD51C, or RAD51D).

Main inclusion criteria: Patients must provide written consent, be at least 18 years old, have ECOG performance status 0-2 (able to walk and perform daily activities), life expectancy of at least 12 weeks, progressive cancer at study entry, confirmed advanced cancer suitable for study treatment, evaluable disease, adequate organ and bone marrow function, and female participants of childbearing potential must have negative pregnancy tests and use effective birth control.

Main exclusion criteria: Patients without specified cancer types or genetic mutations, those with brain metastases not properly managed, outside specified age range, or from vulnerable populations requiring special protection cannot participate.

Trial focus: The study assesses AZD9574’s safety and tolerability when used alone and with other cancer treatments. Participants receive medication as film-coated tablets, with regular monitoring through blood tests, imaging, and health assessments to track treatment effectiveness and side effects.

Investigational drugs: AZD9574 is an experimental medication targeting specific molecular pathways in cancer cells. Anti-cancer agents are medications used in combination with AZD9574 to fight cancer by targeting and killing cancer cells or stopping their growth.

Study of DS-3939a for Patients with Advanced or Metastatic Solid Tumors

This trial tests DS-3939a, a new treatment for advanced solid tumors that have spread or are difficult to treat. The study is divided into two parts: the first evaluates safety and tolerability, while the second measures treatment effectiveness at a recommended dose. Participants may have various cancers including lung, breast, ovary, and pancreatic cancers.

Main inclusion criteria: Patients must sign informed consent, have left ventricular ejection fraction of at least 50%, adequate organ function, measurable disease by RECIST V1.1 criteria, ECOG performance status 0 or 1 (fully active or with some symptoms but able to carry out light work). For Part 1: confirmed diagnosis of locally advanced, metastatic, or unresectable cancer in bladder, lung, breast, ovary, bile duct, or pancreas. For Part 2: confirmed diagnosis meeting study criteria with disease progression, and able to provide baseline tumor sample.

Main exclusion criteria: Patients with metastatic or advanced solid tumors not meeting study criteria, outside specified age range, from vulnerable populations, or not meeting safety and tolerability requirements for DS-3939a cannot participate.

Trial focus: Participants receive DS-3939a through intravenous infusion, with regular monitoring through imaging tests and health assessments. The study evaluates objective response rate (tumor shrinkage percentage), duration of response, time to response, and overall safety through tracking adverse events.

Investigational drugs: DS-3939a is a new medication designed to help treat advanced solid tumors by targeting specific mutations in cancer cells. The trial focuses on understanding safety, side effects, and effectiveness in shrinking or controlling tumors.

Study of personalized FOLFIRINOX drug combination dosing (fluorouracil, irinotecan, oxaliplatin, and calcium folinate) for patients with pancreatic cancer

This study evaluates whether personalizing fluorouracil doses in FOLFIRINOX treatment leads to better results than standard body surface area-based dosing for pancreatic cancer patients. The research measures how the body processes medications and adjusts treatment based on individual patient needs.

Main inclusion criteria: Patients must have confirmed pancreatic cancer diagnosis through biopsy (for Part B: unresectable locally advanced or metastatic), be scheduled to begin FOLFIRINOX treatment, be 18 years or older, provide written informed consent, be willing to undergo additional blood sampling for 5-FU analysis, have WHO performance status 0-2 (able to perform daily activities with some assistance), and can be either male or female.

Main exclusion criteria: Age below 18 or above 75 years, previous FOLFIRINOX treatment, known allergies to study medications, other cancer types besides pancreatic cancer, severe heart/liver/kidney problems, pregnancy or breastfeeding, active infections, participation in other trials within 30 days, mental conditions affecting consent, or inability to follow study procedures.

Trial focus: The study involves two parts: first, patients receive standard FOLFIRINOX doses with blood level measurements; second, patients receive personalized fluorouracil doses based on individual needs. Blood samples are collected throughout treatment to measure medication levels and adjust dosing accordingly.

Investigational drugs: FOLFIRINOX combines fluorouracil (5-FU), irinotecan, oxaliplatin, and leucovorin. 5-FU stops cancer cells from making new DNA, irinotecan blocks cancer cell division, oxaliplatin damages cancer cell DNA, and leucovorin enhances 5-FU effectiveness while reducing side effects. All are given through IV infusion.

Study of SGM-101 fluorescent imaging agent to guide surgery in patients with pancreatic cancer who received prior treatment

This study tests whether SGM-101, a fluorescent imaging agent, can help surgeons better visualize cancer cells during surgery in patients with pancreatic ductal adenocarcinoma who have received prior treatment. The medication makes cancer cells glow under near-infrared light, potentially helping determine if cancer can be completely removed.

Main inclusion criteria: Patients must provide signed informed consent, be over 18 years old, communicate effectively in Dutch or English with study team, follow study requirements and restrictions, have pancreatic cancer that is either borderline resectable (might be surgically removable) or locally advanced (grown into nearby structures), received neoadjuvant treatment and be scheduled for surgical removal, and both men and women may participate.

Main exclusion criteria: Age below 18 or above 65 years, metastatic disease (cancer spread to other body parts), known allergies to antibodies or fluorescent dyes, pregnancy or breastfeeding, participation in another trial within past 30 days, significant heart/kidney/liver disease, history of other cancers in past 5 years (except treated non-melanoma skin cancer), inability to undergo surgery, mental conditions preventing understanding of requirements, use of medications interfering with fluorescent imaging, compromised immune system or active infections, or previous major abdominal surgery affecting results.

Trial focus: Participants receive SGM-101 injection before surgery, then undergo surgery where special cameras detect areas where medication makes cancer cells visible. The study collects blood and tissue samples to evaluate how well this imaging method works in identifying cancer spread and surgical completeness.

Investigational drugs: SGM-101 is a specialized antibody solution that binds to specific markers on pancreatic cancer cells. When injected, it attaches to cancer cells and becomes fluorescent when exposed to near-infrared light during surgery, helping surgeons better visualize tumors and surrounding tissues.

Study of sotorasib with chemotherapy combination for adult patients with advanced pancreatic cancer who have KRAS p.

This study tests sotorasib (LUMYKRAS) combined with standard chemotherapy in patients with advanced pancreatic adenocarcinoma having KRAS p.G12C mutation. The research evaluates whether this combination is safe and well-tolerated, potentially offering a new treatment option for this specific genetic type of pancreatic cancer.

Main inclusion criteria: Patients must be able to give informed consent, at least 18 years old, use effective birth control (women must continue for 7 days after last sotorasib dose, 6 months after gem/nab-P, and 15 months after mFOLFIRINOX; men must use contraception for 12 months after stopping mFOLFIRINOX), have confirmed pancreatic cancer with KRAS p.G12C mutation that has spread locally or to other parts, measurable tumors, good general health (ECOG 0 or 1), life expectancy over 3 months, adequate blood test results showing sufficient white blood cells, hemoglobin, platelets, liver and kidney function, ability to take oral medications, and willingness to record daily medication use.

Main exclusion criteria: Prior treatment with KRAS G12C inhibitors, active untreated/unstable brain metastases, other cancers within 3 years before study (except treated non-melanoma skin/cervical cancer), autoimmune diseases requiring systemic treatment, serious heart conditions (heart attack within 6 months, unstable chest pain, severe rhythm problems), active uncontrolled infections, known allergies to study medications, pregnancy or breastfeeding, conditions making participation unsafe, inability to swallow oral medications, or severe liver/kidney problems.

Trial focus: Participants receive sotorasib tablets daily along with scheduled chemotherapy treatments. Doctors monitor health through regular check-ups, blood tests, and imaging scans to assess treatment effectiveness and watch for side effects. Treatment may continue for up to 9 months depending on response and tolerance.

Investigational drugs: Sotorasib targets specific genetic mutations in cancer cells, particularly KRAS p.G12C mutation, blocking abnormal protein driving cancer growth. Chemotherapy refers to standard first-line drugs used with sotorasib, aiming for more effective treatment approach when combined.

Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer

This trial tests whether total body PET/CT scanning with [68Ga]Ga-FAPI-46 tracer provides better cancer imaging than standard techniques for pancreatic and gastroesophageal cancers. The study compares new imaging method to current practices to determine if it improves diagnosis and treatment planning accuracy.

Main inclusion criteria: Patients must be 18 years or older, able to read and understand Danish patient information to give informed consent. Group A: suspected pancreatic cancer based on standard imaging, CT/MRI showing no initial distant spread, considered suitable for curative surgery at referral. Group B1: confirmed carcinoma from lower esophagus/GEJ/stomach, operable and resectable at referral. Group B2: confirmed SRCC or PCC from lower esophagus/GEJ/stomach, with localized disease assigned to pre-surgery chemotherapy or metastatic disease assigned to symptom-relieving treatment.

Main exclusion criteria: Patients without pancreatic or gastroesophageal cancer, not within specified age range, or part of vulnerable populations requiring special protection cannot participate.

Trial focus: Participants receive [68Ga]Ga-FAPI-46 tracer injection, then undergo PET/CT scan within 30 minutes to evaluate sensitivity in detecting cancerous lesions. A second scan may be conducted 60 minutes after injection to further assess accuracy and specificity. The study evaluates if new imaging method improves diagnostic sensitivity and preoperative staging.

Investigational drugs: [68Ga]Ga-FAPI-46 is a tracer used in total body PET/CT scans, helping doctors see cancer more clearly by targeting fibroblast activation protein often overexpressed in cancerous tissues, allowing better imaging for diagnosis and treatment planning.

Summary

The 48 ongoing clinical trials for pancreatic carcinoma represent a diverse range of treatment approaches and research settings across multiple European countries. Several notable observations emerge from this comprehensive overview:

Geographic distribution: The trials are concentrated primarily in Northern and Western Europe, with the Netherlands, Sweden, France, Spain, and Germany leading in number of studies. This concentration reflects these countries’ established research infrastructure and healthcare systems capable of supporting complex oncology trials.

Treatment focus areas: A significant portion of trials investigate combination chemotherapy regimens, particularly variations of FOLFIRINOX and gemcitabine-based treatments. Multiple studies explore timing questions (neoadjuvant versus adjuvant therapy), personalized dosing approaches, and combination strategies with immunotherapy agents.

Emerging therapies: Several trials evaluate novel approaches including targeted therapies for specific genetic mutations (KRAS, PALB2, HER2), immunotherapy combinations, and innovative imaging techniques using radioactive tracers for better tumor visualization and treatment planning.

Patient populations: The trials cover the full spectrum of disease stages from resectable to metastatic pancreatic cancer, with some studies specifically designed for patients who cannot tolerate intensive treatment regimens, addressing an important unmet need in fragile patient populations.

Surgical innovations: Several studies investigate surgical techniques and perioperative management, including methods to prevent post-surgical complications and approaches combining surgery with systemic therapies.

This extensive research activity demonstrates the oncology community’s commitment to improving outcomes for pancreatic cancer patients through multiple complementary approaches, from optimizing existing treatments to developing entirely new therapeutic strategies.

Ongoing Clinical Trials on Pancreatic carcinoma

  • A study to evaluate the use of FAPI-46 (68Ga) imaging to detect peritoneal cancer spread in patients with colorectal, gastric, ovarian, or pancreatic cancer

    Recruiting

    4 1 1
    The Netherlands Sweden
  • Study on Clopidogrel and Dalteparin Sodium for Preventing Blood Clots in Pancreatic Cancer Patients

    Recruiting

    3 1 1 1
    Investigated diseases:
    Norway
  • Study Comparing Gemcitabine and Paclitaxel with Drug Combination for Patients with Advanced Pancreatic Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Italy
  • Study on the Effectiveness of Laparoscopic Electrochemotherapy with Bleomycin Sulfate for Patients with Locally Advanced Pancreatic Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Italy
  • Study on the Effectiveness of Paclitaxel and Gemcitabine for Patients with Pancreatic Cancer Spread to the Abdomen

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy
  • Study on Preventing Blood Clots in Pancreatic Cancer Patients Using Tinzaparin Sodium and Enoxaparin Sodium During Treatment

    Recruiting

    3 1 1 1
    Finland
  • Title: Evaluation of Gallium-68 FAPI-46 PET Imaging for Better Detection and Monitoring of Pancreatic Cancer and Bile Duct Cancer

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands
  • Study on PBP1510 and Gemcitabine for Patients with Advanced Pancreatic Cancer After Previous Chemotherapy

    Recruiting

    2 1 1
    Spain
  • A Study of FOLFIRINOX Drug Combination Before Surgery Compared to Immediate Surgery in Patients with Resectable Pancreatic Head Cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Norway Sweden
  • Study on FOLFIRINOX, Pembrolizumab, and SABR for Patients with Borderline Resectable Pancreatic Cancer

    Recruiting

    1 1 1 1
    The Netherlands