Ongoing Clinical Trials for Cholangiocarcinoma

There are currently 30 clinical trials worldwide studying new treatments for cholangiocarcinoma, a type of cancer affecting the bile ducts. These trials are testing various approaches including targeted therapies, immunotherapies, chemotherapy combinations, and specialized radiation treatments. Trials are being conducted across Europe, with the highest concentration in Germany, France, Italy, Spain, and the Netherlands.

Clinical trial locations

Featured Clinical Trials

Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

This trial is investigating futibatinib, a targeted therapy for patients with advanced cholangiocarcinoma who have specific genetic changes called FGFR2 fusions or rearrangements. The study focuses on patients whose cancer has progressed after treatment with gemcitabine and platinum-based chemotherapy.

Main inclusion criteria: Patients must have confirmed advanced cholangiocarcinoma that cannot be removed surgically or has spread to other parts of the body. Evidence of FGFR2 gene fusions or rearrangements must be documented through approved testing methods. Previous treatment with gemcitabine and platinum-based chemotherapy is required, with documented disease progression. Patients must have measurable disease according to RECIST criteria, an ECOG performance status of 0 or 1, and adequate organ function.

Main exclusion criteria: Patients with cancer types other than advanced cholangiocarcinoma are excluded. Those outside the specified age range, unable to take oral medication as prescribed, or not meeting specific health criteria cannot participate.

Trial focus: The primary goal is to evaluate the overall response rate to futibatinib treatment, which measures how many patients experience tumor shrinkage or cancer stabilization. The study will monitor safety through assessment of adverse events, laboratory tests, eye examinations, and vital signs monitoring. Quality of life will be measured using standardized questionnaires. The trial also tracks progression-free survival and overall survival.

Investigational drug: Futibatinib is an oral medication taken as film-coated tablets in doses of 16 mg or 20 mg once daily. It works by blocking the FGFR2 protein, which is involved in cancer cell growth. As a tyrosine kinase inhibitor, it represents a targeted therapy approach specifically designed for patients with FGFR2 alterations.

Study of Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin for Patients with Advanced Cholangiocarcinoma with IDH1 Mutation

This trial examines a combination approach for treating advanced cholangiocarcinoma with IDH1 mutations. The study tests ivosidenib (a targeted therapy) combined with durvalumab (an immunotherapy) plus standard chemotherapy drugs gemcitabine and cisplatin as first-line treatment.

Main inclusion criteria: Patients must have confirmed advanced cholangiocarcinoma that is locally advanced, unresectable, or metastatic. Documentation of an IDH1 mutation is required. At least one measurable tumor must be present. Adequate bone marrow, liver, and kidney function are necessary. Patients should have an ECOG performance status of 0 or 1, demonstrating ability to carry out normal activities with minimal restrictions.

Main exclusion criteria: Patients without the specific IDH1 mutation, those who have received previous treatment for their advanced disease, and those with other serious health conditions that could interfere with study treatment are excluded.

Trial focus: The study has two phases. The safety lead-in phase determines the appropriate dose of ivosidenib when combined with other medications. The expansion phase evaluates the clinical activity of the full combination. The trial monitors tumor response, overall health changes, and potential side effects through regular blood tests and imaging studies.

Investigational drugs: Ivosidenib is an oral medication (250 mg tablets) that inhibits the mutated IDH1 enzyme. Durvalumab is an intravenous immunotherapy that blocks the PD-L1 protein, helping the immune system recognize cancer cells. Gemcitabine and cisplatin are standard chemotherapy drugs given intravenously that work by interfering with cancer cell DNA.

Study of Radioembolization Combined with Cisplatin, Gemcitabine and Durvalumab Treatment in Patients with Unresectable Liver Cholangiocarcinoma

This trial combines radioembolization with systemic therapy for liver-predominant intrahepatic cholangiocarcinoma that cannot be surgically removed. The study evaluates the effectiveness and safety of radioembolization followed by chemotherapy and immunotherapy.

Main inclusion criteria: Patients must have intrahepatic cholangiocarcinoma confirmed by tissue examination that is not suitable for surgery. The disease should be predominantly in the liver with liver-predominant involvement. Age between 18 and 80 years is required. Adequate liver function (Child-Pugh Class A), good general health (ECOG 0 or 1), and life expectancy of at least 12 weeks are necessary. Blood tests must show adequate hemoglobin, platelet, and white blood cell counts, as well as normal kidney function.

Main exclusion criteria: Previous immunotherapy treatment, active autoimmune disease within the past 2 years, untreated brain metastases, organ transplant history, pregnancy or breastfeeding, serious heart conditions, and other active cancers requiring treatment are excluded.

Trial focus: The treatment begins with radioembolization (TARE), a procedure delivering radiation directly to liver tumors through blood vessels. This is followed by combined treatment with cisplatin, gemcitabine, and durvalumab administered over six months. Regular monitoring through imaging tests and blood work evaluates tumor response and safety.

Investigational drugs: Cisplatin and gemcitabine are chemotherapy drugs given intravenously that interfere with cancer cell DNA. Durvalumab is an immunotherapy given intravenously that blocks the PD-L1 protein. Radioembolization uses tiny radioactive beads delivered directly to liver tumors for targeted radiation therapy.

Study on Durvalumab, Cisplatin, and Gemcitabine for Patients with Extrahepatic Cholangiocarcinoma

This trial examines the combination of immunotherapy with chemotherapy and a specialized procedure for extrahepatic cholangiocarcinoma, which affects bile ducts outside the liver.

Main inclusion criteria: Patients must have provided written informed consent. Female patients of childbearing potential or male patients with partners who can become pregnant must agree to use effective birth control. Minimum age is 18 years. Patients must have histologically confirmed cholangiocarcinoma eligible for palliative systemic therapy. ECOG performance status should be 0 or 1 with life expectancy of at least 12 weeks. Body weight must exceed 30 kg. Adequate blood, liver, and kidney function is required.

Main exclusion criteria: The specific exclusion criteria were not provided in the source material.

Trial focus: The study evaluates overall survival rate at 12 months as the primary endpoint. Secondary objectives include progression-free survival, safety assessment, time to develop bile duct infection, and quality of life measurements. The treatment combines cisplatin and gemcitabine chemotherapy with durvalumab immunotherapy and intraductal radiofrequency ablation.

Investigational drugs: Durvalumab is an immunotherapy administered intravenously that blocks the PD-L1 protein to help the immune system fight cancer. Intraductal radiofrequency ablation is a procedure that uses heat to destroy cancer cells in the bile ducts.

Study on Ivosidenib for Patients with Previously Treated Advanced or Metastatic Cholangiocarcinoma

This trial provides early access to ivosidenib for patients with advanced cholangiocarcinoma who have IDH1 mutations and have already received at least one previous treatment.

Main inclusion criteria: Patients must be at least 18 years old with locally advanced or metastatic cholangiocarcinoma that cannot be removed surgically. A confirmed IDH1 mutation (R132C, R132L, R132G, R132H, or R132S) through local testing is required. Previous treatment with at least one line of systemic therapy is necessary. ECOG performance status should be 0 or 1. Adequate bone marrow, liver, and kidney function must be documented.

Main exclusion criteria: Patients who have not received previous treatment, those with certain serious health conditions, pregnant or breastfeeding women, those unable to follow study procedures, those with allergies to study medications, participants in other trials, those with certain heart conditions, uncontrolled infections, or recent major surgery are excluded.

Trial focus: The study evaluates the safety of ivosidenib through monitoring of adverse events. Secondary objectives include assessing tumor response rates, progression-free survival, overall survival, and quality of life using disease-specific questionnaires. Regular monitoring includes physical examinations, blood tests, and electrocardiograms.

Investigational drug: Ivosidenib is an oral medication taken as film-coated tablets. It works by inhibiting the mutated IDH1 enzyme involved in cancer cell growth, representing a targeted therapy approach for patients with this specific genetic alteration.

Study on Pre-Surgery Treatment for Locally Advanced Cholangiocarcinoma Using Durvalumab, Tremelimumab, Cisplatin, and Gemcitabine

This trial evaluates neoadjuvant treatment (treatment before surgery) combining immunotherapy with chemotherapy for locally advanced cholangiocarcinoma.

Main inclusion criteria: Patients must be over 18 years old with confirmed locally advanced cholangiocarcinoma. The disease should initially be unresectable as determined by a multidisciplinary surgical team, with specific criteria including tumor proximity to remaining liver or portal vein, up to three metastases in the remaining liver, or lymph node involvement. Life expectancy should be at least 16 weeks with body weight over 30 kg. Normal organ and bone marrow function is required. ECOG performance status should be 0 or 1. At least one measurable tumor and no previous treatments are necessary.

Main exclusion criteria: Patients with any other cancer type, previous cancer treatment within 5 years, severe heart disease, uncontrolled high blood pressure, active infections, pregnancy or breastfeeding, inability to follow study procedures, drug or alcohol abuse history, or participation in other recent trials are excluded.

Trial focus: The primary objective is determining the recurrence rate 12 months after surgery. The study monitors whether this combination treatment can reduce cancer recurrence chances. Regular assessments track tumor response, surgical outcomes, and patient health throughout treatment and recovery.

Investigational drugs: Durvalumab and tremelimumab are immunotherapy medications given intravenously that help the immune system recognize and attack cancer cells by blocking specific proteins. Cisplatin and gemcitabine are chemotherapy drugs also given intravenously.

Study on Preventing Liver Recurrence in Patients with Intrahepatic Cholangiocarcinoma Using Floxuridine via Hepatic Arterial Infusion Pump

This trial investigates hepatic arterial infusion pump chemotherapy as an adjuvant treatment after surgery to prevent cancer recurrence in the liver.

Main inclusion criteria: Patients must be at least 18 years old with ECOG performance status 0 or 1. Resectable intrahepatic cholangiocarcinoma diagnosed through imaging is required (no tissue confirmation needed before surgery). Ability to undergo laparotomy and technical feasibility for catheter placement for HAIP chemotherapy must be confirmed. Adequate bone marrow, liver, and kidney function demonstrated through specific laboratory values is necessary. Written informed consent must be provided.

Main exclusion criteria: Patients with other cancer types, those unable to undergo surgery for cancer removal, those unable to receive the specific chemotherapy method, pregnant or breastfeeding women, and those with serious interfering health conditions are excluded.

Trial focus: The primary goal is achieving two-year hepatic recurrence-free survival. The study involves partial hepatectomy followed by HAIP chemotherapy delivered directly to the liver through a catheter placed during surgery. Regular monitoring tracks liver recurrence, overall survival, quality of life, and adverse events.

Investigational drug: Hepatic Arterial Infusion Pump Chemotherapy delivers chemotherapy directly to the liver through a pump, concentrating medication in the liver to target cancer cells more effectively while potentially reducing systemic side effects.

Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients

This trial evaluates a combination treatment approach for previously untreated HER2-positive biliary tract cancers, including cholangiocarcinoma and gallbladder cancer.

Main inclusion criteria: Patients must provide written informed consent and have adequate organ function. Age must be at least 18 years. Confirmed diagnosis of HER2-positive cholangiocarcinoma or gallbladder cancer that is not eligible for surgery is required. ECOG performance status should be 0 to 1. At least one measurable tumor and agreement to use contraception are necessary. For hepatitis B or C patients, specific viral load and treatment requirements must be met.

Main exclusion criteria: Patients with other cancer types, those outside the specified age range, those not in specified trial groups, or those unable to provide informed consent are excluded.

Trial focus: The primary objective is evaluating the objective response rate at six months, measuring how many patients experience significant tumor reduction. The study monitors progression-free survival, overall survival, treatment duration, and safety. Regular assessments include imaging tests and blood work.

Investigational drugs: GemCis combines gemcitabine and cisplatin chemotherapy. Trastuzumab is a targeted therapy attaching to HER2 protein on cancer cells. Pembrolizumab is an immunotherapy that helps the immune system detect and fight cancer by blocking the PD-1 pathway.

Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

This trial examines tinengotinib as a treatment option for patients whose cholangiocarcinoma has not responded to both standard chemotherapy and previous FGFR inhibitor treatment.

Main inclusion criteria: Patients must be at least 18 years old with confirmed cholangiocarcinoma or bile duct adenocarcinoma that cannot be surgically removed or has spread. Documentation of FGFR2 gene changes is required. Previous treatment with at least one chemotherapy regimen and exactly one FDA-approved FGFR inhibitor is necessary. Measurable disease by imaging, ECOG performance status 0 to 1, adequate organ function, and agreement to blood sampling for liquid biopsy and use of birth control are required.

Main exclusion criteria: Patients without cholangiocarcinoma diagnosis, those without FGFR gene changes, those who haven’t received previous treatments, those outside specified age ranges, those unwilling to follow procedures, pregnant or breastfeeding women, and those with interfering medical conditions are excluded.

Trial focus: The study has two parts: Part A assesses safety and tolerability of different tinengotinib doses, while Part B evaluates effectiveness compared to physician’s choice of treatment. The trial monitors progression-free survival, overall survival, and side effects through regular assessments.

Investigational drug: Tinengotinib is an oral medication (8 mg or 10 mg tablets taken once daily) that targets and inhibits FGFR, representing a targeted therapy specifically for patients with FGFR2 alterations whose cancer has progressed despite previous treatments.

Study on the Effectiveness of Floxuridine with Gemcitabine and Oxaliplatin for Patients with Intra-hepatic Cholangiocarcinoma Not Suitable for Surgery

This trial compares two treatment approaches for inoperable intrahepatic cholangiocarcinoma: systemic chemotherapy alone versus systemic chemotherapy combined with hepatic arterial infusion.

Main inclusion criteria: Patients must have confirmed intrahepatic cholangiocarcinoma with disease confined to the liver, WHO/ECOG performance status 0 or 1, and life expectancy of at least 12 weeks. The disease must be unresectable (meaning tumor cannot be completely removed without affecting important blood vessels, or there are multiple tumors, or cancer has returned after surgery, or nearby lymph nodes are involved). At least one measurable tumor larger than 2 cm is required. Adequate organ function is necessary.

Main exclusion criteria: Patients with metastatic cancer, resectable cancer, cancer outside the liver, serious health conditions, inability to follow procedures, pregnancy or breastfeeding, allergies to study medications, recent participation in other trials, certain heart conditions, uncontrolled infections, and recent major surgery are excluded.

Trial focus: The primary endpoint is median survival time. Secondary endpoints include one-year and two-year survival rates, tumor response rate, and quality of life changes. Patients are randomly assigned to receive either systemic GemOx chemotherapy alone or systemic GemOx plus HAI FUDR/Dex therapy.

Investigational drugs: HAI-FUDR/DEX delivers chemotherapy directly to the liver through arteries, potentially targeting cancer more effectively. SIRT uses radioactive beads to deliver radiation directly to liver tumors. GemOx is a combination of gemcitabine and oxaliplatin chemotherapy drugs used to control cancer growth.

Study on the Effectiveness of Yttrium-90 Microspheres and Capecitabine for Patients with Operable Intrahepatic Cholangiocarcinoma

This trial evaluates neoadjuvant treatment combining Selective Internal Radiation Therapy with capecitabine chemotherapy before surgery for operable intrahepatic cholangiocarcinoma.

Main inclusion criteria: Patients must be over 18 years old with ECOG Performance Status less than 2, confirmed diagnosis of intrahepatic cholangiocarcinoma without previous treatment, tumor considered removable by surgery as confirmed by surgical experts, and significant risk of close surgical margins (space between tumor and removed tissue edge less than 1 cm, tumor larger than 5 cm, or multiple removable tumors). Registration with social security and signed consent are required.

Main exclusion criteria: No specific exclusion criteria were listed in the provided information.

Trial focus: The study evaluates whether neoadjuvant treatment can improve surgical outcomes, specifically measuring adequate surgical margin rates and percentage of destroyed cancer tissue. Regular monitoring includes imaging and laboratory assessments throughout treatment and follow-up periods.

Investigational drugs: Selective Internal Radiation Therapy uses Yttrium-90 glass microspheres (tiny radioactive beads) injected into blood vessels supplying the tumor, delivering high radiation doses directly to cancer cells. Capecitabine is oral chemotherapy interfering with cancer cell growth, used to enhance treatment effectiveness.

Summary

The 30 clinical trials for cholangiocarcinoma demonstrate a strong concentration of research in Western Europe, particularly Germany, France, Italy, Spain, and the Netherlands. Germany stands out with the highest number of trials (at least 10), followed by France with 9 trials, reflecting these countries’ robust oncology research infrastructure.

The trials reveal several notable treatment approaches. A significant focus exists on targeted therapies, particularly drugs targeting FGFR2 alterations (futibatinib, pemigatinib, tinengotinib) and IDH1 mutations (ivosidenib). Many studies combine immunotherapy (durvalumab, tremelimumab, pembrolizumab) with standard chemotherapy (gemcitabine and cisplatin), suggesting a trend toward combination treatment strategies.

Specialized approaches include hepatic arterial infusion chemotherapy for liver-predominant disease and radioembolization techniques, demonstrating innovation in regional therapy delivery. Several trials focus on specific patient populations, such as those with HER2-positive disease or those who have failed previous treatments, addressing unmet needs in treatment-resistant cases.

The trials span different treatment settings: neoadjuvant therapy before surgery, adjuvant therapy after surgery, and treatment for advanced unresectable disease. This comprehensive approach reflects efforts to improve outcomes at various stages of the disease. Quality of life assessment is commonly included as a secondary endpoint, showing attention to patient wellbeing beyond survival metrics.

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Cholangiocarcinoma – Trials in Disease

Ongoing Clinical Trials for Cholangiocarcinoma

Clinical trial locations

Featured Clinical Trials

Study of Futibatinib for Patients with Advanced Cholangiocarcinoma with FGFR2 Fusions or Rearrangements

Study of Ivosidenib, Durvalumab, and Gemcitabine/Cisplatin for Patients with Advanced Cholangiocarcinoma with IDH1 Mutation

Study of Radioembolization Combined with Cisplatin, Gemcitabine and Durvalumab Treatment in Patients with Unresectable Liver Cholangiocarcinoma

Study on Durvalumab, Cisplatin, and Gemcitabine for Patients with Extrahepatic Cholangiocarcinoma

Study on Ivosidenib for Patients with Previously Treated Advanced or Metastatic Cholangiocarcinoma

Study on Pre-Surgery Treatment for Locally Advanced Cholangiocarcinoma Using Durvalumab, Tremelimumab, Cisplatin, and Gemcitabine

Study on Preventing Liver Recurrence in Patients with Intrahepatic Cholangiocarcinoma Using Floxuridine via Hepatic Arterial Infusion Pump

Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients

Study on the Effectiveness and Safety of Tinengotinib for Patients with Cholangiocarcinoma Resistant to Chemotherapy and FGFR Inhibitors

Study on the Effectiveness of Floxuridine with Gemcitabine and Oxaliplatin for Patients with Intra-hepatic Cholangiocarcinoma Not Suitable for Surgery

Study on the Effectiveness of Yttrium-90 Microspheres and Capecitabine for Patients with Operable Intrahepatic Cholangiocarcinoma

Summary

Ongoing Clinical Trials on Cholangiocarcinoma

Study of Durvalumab, Tremelimumab, and Capecitabine for Patients with Biliary Tract Cancer in an Adjuvant Setting

Study on Gemcitabine and Cisplatin for Patients After Surgery for Bile Duct or Gallbladder Cancer

Study of Tucatinib and Trastuzumab for Patients with Advanced Solid Tumors with HER2 Changes

Study of Durvalumab with Gemcitabine and Cisplatin for Patients with Advanced Biliary Tract Cancer

Study on the Effectiveness and Safety of Gemcitabine, Cisplatin, Trastuzumab, and Pembrolizumab for Untreated HER2-Positive Biliary Tract Cancer Patients

Study on the Effects of Volrustomig and Drug Combination for Patients with Advanced Hepatobiliary Cancer

Study on the Safety of LSTA1 with Standard Care for Patients with Advanced Head and Neck Cancer or Cholangiocarcinoma

Study on Preoperative Treatment with Gemcitabine, Cisplatin, Durvalumab, and Tremelimumab for Patients with Intrahepatic Cholangiocarcinoma

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Cholangiocarcinoma – Trials in Disease

Ongoing Clinical Trials for Cholangiocarcinoma

Clinical trial locations

Featured Clinical Trials

Summary

Ongoing Clinical Trials on Cholangiocarcinoma

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