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Oesophageal carcinoma – Trials in Disease

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Ongoing Clinical Trials for Oesophageal Carcinoma

There are currently 19 clinical trials ongoing across Europe studying new treatments for oesophageal carcinoma. These trials are testing various approaches including immunotherapy, targeted therapy, chemotherapy combinations, and supportive care interventions. Trials are being conducted in multiple countries including the Netherlands, Spain, France, Germany, Italy, Belgium, Denmark, and several others.

Clinical trial locations

Study of HLX22, Trastuzumab, and Chemotherapy for Patients with Advanced or Metastatic Stomach and Gastroesophageal Cancer

This trial is testing a new treatment combination for patients with advanced gastroesophageal cancer. The study focuses on patients whose cancer has spread or cannot be surgically removed.

Main inclusion criteria: Participants must be at least 18 years old with confirmed HER2-positive gastroesophageal junction or gastric cancer. Patients need to have measurable disease and adequate organ function, including heart function with an ejection fraction greater than 50%. Women of childbearing potential must use reliable birth control methods during the study and for nine months after the last treatment dose.

Main exclusion criteria: Patients who have already received treatment for their advanced cancer, those with serious heart conditions, pregnant or breastfeeding women, and individuals with known allergies to the study medications cannot participate. Patients participating in other clinical trials simultaneously may also be excluded.

Study focus: The trial compares HLX22 combined with trastuzumab and chemotherapy to standard treatment with or without pembrolizumab. The main goal is to evaluate progression-free survival, measuring how long patients live without cancer worsening, and overall survival.

Investigational drugs: HLX22 is a recombinant humanized anti-HER2 monoclonal antibody that helps the immune system recognize and attack cancer cells. Trastuzumab also targets the HER2 protein, blocking signals that promote cancer cell growth. The study may include pembrolizumab, an immune checkpoint inhibitor, and XELOX chemotherapy combining capecitabine and oxaliplatin.

Study of trastuzumab with chemotherapy and immunotherapy combination for first-line treatment in patients with HER2-positive esophageal squamous cell cancer

This trial evaluates adding trastuzumab to standard treatment for patients with HER2-positive esophageal squamous cell carcinoma. The study specifically targets patients whose cancer cells have high levels of the HER2 protein.

Main inclusion criteria: Patients must have inoperable advanced or metastatic HER2-positive esophageal cancer confirmed by laboratory testing. Participants need to be at least 18 years old with an ECOG performance status less than 2, meaning they can carry out light daily activities. Heart function must show pumping ability greater than 50%, and blood tests must meet specific requirements for white blood cells, liver, and kidney function.

Main exclusion criteria: Patients who have previously received trastuzumab for esophageal cancer, those with known allergies to pembrolizumab or its components, and individuals with active autoimmune diseases cannot participate. Untreated brain metastases, significant heart problems, severe liver or kidney problems, pregnancy or breastfeeding, and inability to swallow oral medications are also exclusion criteria.

Study focus: The trial tests whether adding trastuzumab to pembrolizumab and chemotherapy improves treatment outcomes compared to standard therapy. The study monitors participants for six months, evaluating response to treatment and assessing heart function and blood test results throughout.

Investigational drugs: Trastuzumab is a targeted monoclonal antibody that binds to HER2 proteins on cancer cells. Pembrolizumab is an immunotherapy medication that blocks the PD-1 protein, enabling the immune system to better attack cancer cells. Fluoropyrimidine chemotherapy interferes with cancer cell growth by preventing DNA synthesis.

Study on Preventing Infections After Esophageal Cancer Surgery Using Colistin Sulfate, Tobramycin, and Amphotericin B in Patients with Resectable Esophageal Cancer

This trial studies whether a specific combination of antibiotics can prevent severe infections, particularly pneumonia, after surgery to remove part of the esophagus in cancer patients.

Main inclusion criteria: Patients must have primary esophageal adenocarcinoma or squamous cell carcinoma located in the mid or distal esophagus or at the gastro-esophageal junction. The cancer must be confirmed by biopsy and be surgically removable. Participants need to be at least 18 years old and scheduled for transthoracic esophagectomy with curative intent. Both men and women can participate if they provide written informed consent.

Main exclusion criteria: Patients without esophageal cancer diagnosis, those outside the specified age range, and individuals belonging to vulnerable populations cannot participate in this study.

Study focus: The trial evaluates Selective Decontamination of the Digestive tract treatment given for up to seven days to reduce harmful bacteria in the digestive system. The primary goal is preventing postoperative pneumonia within 30 days after surgery. Secondary outcomes include monitoring other infections, surgical site leakage, quality of life, and recovery metrics.

Investigational drugs: SDD therapy uses a combination of non-absorbable antibiotics including colistin sulfate and tobramycin administered orally, along with amphotericin B. These medications target specific bacteria to minimize infection risk following esophageal surgery.

Study on the Effectiveness and Safety of BAY 2927088 for Patients with Advanced Solid Tumors with HER2 Mutations

This trial tests a new medication called BAY 2927088 in patients with advanced solid tumors that have specific HER2 mutations. The study includes various cancer types, including esophageal cancer.

Main inclusion criteria: Patients must be at least 18 years old with advanced solid tumors that have HER2-activating mutations and cannot be surgically removed. Participants should have already tried standard treatments or have no satisfactory alternatives available. At least one measurable cancer area must be present, determined by RECIST 1.1 criteria.

Main exclusion criteria: Patients without HER2 mutations, those unwilling or unable to follow study procedures, pregnant or breastfeeding women, and individuals with certain medical conditions that could interfere with the study cannot participate. Recent participation in other clinical trials may also be exclusionary.

Study focus: The trial monitors participants for up to 36 months to determine how well BAY 2927088 works and its safety profile. Regular assessments track tumor response, disease control duration, and effects on quality of life. The study aims to provide information for better treatment options for patients with HER2-mutated tumors.

Investigational drugs: BAY 2927088 is an oral medication taken as a coated tablet. It works as a reversible tyrosine kinase inhibitor, blocking specific proteins that help cancer cells grow. The medication specifically targets tumors with HER2-activating mutations.

Study on the Effectiveness of Botensilimab and Balstilimab for Patients with Various dMMR and pMMR Tumors

This trial studies a combination of two investigational drugs for patients with various cancers, including esophageal cancer. The medications aim to enhance the immune system’s ability to fight cancer.

Main inclusion criteria: Participants must be at least 18 years old with non-metastatic cancer including sarcoma, cervical, head and neck, anal, or esophageal cancer. Patients must sign written informed consent and be eligible for study biopsy. A WHO performance status of 0 or 1 is required, meaning full activity or light work capability. Blood tests must show adequate white blood cells, platelets, hemoglobin, and normal liver and kidney function within 7 days before starting.

Main exclusion criteria: Patients with a history of severe allergic reactions to similar drugs, those who are pregnant or breastfeeding, individuals with active infections requiring treatment, and those with other serious health conditions cannot participate. Recent major surgery, drug or alcohol abuse history, and inability to comply with study procedures are also exclusionary.

Study focus: The trial evaluates botensilimab and balstilimab administered through intravenous infusion. The primary goal is determining the major pathologic response rate, aiming for 10% or less viable tumor remaining after treatment. The study also assesses safety and feasibility before surgery.

Investigational drugs: Botensilimab and balstilimab are investigational medications designed to help the immune system recognize and attack cancer cells. Both are being studied for their potential to improve treatment outcomes when used together in patients with certain tumor types.

Study on the Safety and Effectiveness of Trastuzumab Deruxtecan and Drug Combination for Patients with HER2-Positive Gastric, GEJ, and Esophageal Cancer

This trial investigates trastuzumab deruxtecan alone and in combination with other medications for HER2-expressing gastric, gastroesophageal junction, and esophageal cancer.

Main inclusion criteria: Participants must be at least 18 years old with HER2-positive adenocarcinoma confirmed by central laboratory testing. Patients need measurable disease according to specific criteria and adequate bone marrow, heart, kidney, and liver function. For some study parts, patients must have cancer progression after trastuzumab treatment; for others, no prior treatment for unresectable or metastatic disease is allowed. Women of childbearing potential must use effective birth control for 7 months after treatment, men for 4-6 months depending on treatment group.

Main exclusion criteria: Patients without HER2-expressing cancer, those unwilling to follow study procedures, pregnant or breastfeeding women, individuals with certain heart conditions or other serious health issues, and those taking interfering medications cannot participate. Recent participation in other clinical trials may also exclude patients.

Study focus: The study is divided into parts determining the safest dose of trastuzumab deruxtecan when combined with other medications, then assessing how well these combinations control cancer. Participants receive treatments through intravenous infusion or oral tablets, monitored regularly for side effects and cancer response.

Investigational drugs: Trastuzumab deruxtecan delivers chemotherapy directly to cancer cells by targeting HER2 protein. Capecitabine and 5-fluorouracil disrupt cancer cell DNA and RNA, while oxaliplatin damages cancer cell DNA. Durvalumab helps the immune system recognize and attack cancer cells by blocking proteins that prevent immune response.

Study to Determine the Best Dose of Zongertinib with Trastuzumab Deruxtecan or Trastuzumab Emtansine for Patients with Advanced HER2+ Metastatic Cancer

This trial tests zongertinib in combination with other medications for patients with HER2-positive metastatic breast cancer and metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma.

Main inclusion criteria: Patients must be at least 18 years old with documented HER2-positive metastatic cancer that has progressed after at least one previous treatment. Participants need at least one measurable lesion according to RECIST 1.1 criteria, an ECOG score of 0 or 1, and adequate organ function based on laboratory tests. For dose optimization phase, tumor tissue from non-radiated areas must be provided.

Main exclusion criteria: Patients with other cancer types not specified in the study, those unable to follow the treatment plan and schedule, individuals who started other anti-cancer treatments before study treatment shows results, and vulnerable populations cannot participate.

Study focus: The study has two phases: Phase Ib gradually increases zongertinib dose to determine the highest safe dose, while Phase II evaluates effectiveness at shrinking tumors or stopping growth. Participants receive zongertinib orally as film-coated tablets combined with either trastuzumab deruxtecan or trastuzumab emtansine given intravenously, with regular monitoring until 2028.

Investigational drugs: Zongertinib is an oral medication being tested in combination to determine optimal tolerable doses. Trastuzumab deruxtecan and trastuzumab emtansine are intravenous medications delivering chemotherapy directly to HER2-positive cancer cells, helping stop their growth.

Study of Avelumab with Chemotherapy for Patients with Resectable Stomach or Gastroesophageal Junction Cancer

This trial studies adding avelumab to chemotherapy for patients with surgically removable gastric or gastroesophageal junction cancer.

Main inclusion criteria: Patients must have biopsy-confirmed gastric or gastroesophageal junction cancer that can be surgically removed. Cancer must be at UICC tumor stage Ib to IIIC based on CT scan, and patients must be healthy enough for surgery as determined by a medical team. Participants need to be at least 18 years old with WHO performance status of 0 or 1, meaning they can perform daily activities. Women of childbearing potential must use effective birth control during the study and for 12 months after last treatment, with negative pregnancy tests required. Men must agree to use condoms and additional birth control for 12 months after treatment. Normal organ function shown by specific blood tests within 7 days before starting is required.

Main exclusion criteria: Patients with cancer types other than resectable gastric or gastroesophageal junction cancer, those outside specified age ranges, individuals unable to receive neoadjuvant chemotherapy, and those with medical conditions making participation unsafe cannot join. Vulnerable populations not designed for study inclusion are excluded.

Study focus: The trial tests whether adding avelumab to chemotherapy improves outcomes compared to chemotherapy alone. Treatment includes docetaxel, oxaliplatin, and fluorouracil combined with calcium folinate, all given intravenously. The study aims to achieve complete response, meaning no remaining cancer cells in surgically removed tissue, while monitoring overall survival and disease-free survival.

Investigational drugs: Avelumab is immunotherapy helping the immune system recognize and attack cancer cells. Docetaxel stops cancer cell growth by interfering with cell division. Oxaliplatin damages cancer cell DNA preventing growth and division. Fluorouracil interferes with DNA and RNA production essential for cell growth. Leucovorin enhances fluorouracil effectiveness by stabilizing the drug’s bond with cancer cell DNA.

Study of Chemoradiation with Carboplatin and Paclitaxel for Elderly Patients with Esophageal Cancer

This trial studies treatments combining carboplatin, paclitaxel, and radiation therapy for elderly esophageal cancer patients.

Main inclusion criteria: Patients must be 75 years or older with respiratory function showing breathing test results of 1 liter per second or more. Specific geriatric criteria include GDS 15 score less than 7, MMSE score more than 23, at least one caregiver or helper, walking speed more than 0.8 meters per second without recent falls, and appropriate Charlson scores based on age. Patients need sufficient calorie intake of 1000 calories per square meter per day and lab-confirmed esophageal cancer at stage T1T2T3, N0-1, M0-M1a that is inoperable. Blood tests must show adequate cell counts and organ function.

Main exclusion criteria: Pregnant or breastfeeding women, individuals with other cancer history except certain skin cancers, those with severe heart problems, uncontrolled infections, major surgery within last 4 weeks, known allergies to study drugs, severe allergic reaction history, significant liver or kidney problems, recent investigational drug participation, and drug or alcohol abuse history cannot participate.

Study focus: The study has two phases: Phase I tests different doses to find the maximum tolerable dose, while Phase II assesses effectiveness at recommended dose by checking cancer response after 12 weeks. The goal is determining if carboplatin, paclitaxel, and radiation therapy combination can lead to complete tumor response while monitoring side effects and quality of life.

Investigational drugs: Carboplatin is chemotherapy interfering with cancer cell DNA, preventing growth and division. Paclitaxel stops cancer cell growth by inhibiting their division ability. Radiotherapy uses high-energy rays to target and kill cancer cells, tested at various total doses combined with chemotherapy.

Study of Ferumoxtran-10 Enhanced MRI for Detecting Lymph Node Metastases in Patients with Esophageal Cancer

This study evaluates a special imaging method using Ferrotran contrast agent to better detect cancer spread to lymph nodes in esophageal cancer patients.

Main inclusion criteria: Patients must have confirmed esophageal adenocarcinoma proven through tissue examination and be scheduled for both neoadjuvant chemoradiotherapy and esophagectomy. A WHO performance score between 0-2 is required, meaning ability to perform daily activities. Participants must be at least 18 years old, able and willing to provide written informed consent. Both men and women may participate.

Main exclusion criteria: Age below 18 or above 65 years, inability to undergo MRI scanning due to metal implants, pacemakers, or claustrophobia, known allergy to USPIO contrast agents, pregnant or breastfeeding women, severe kidney disease, active infections or serious medical conditions, previous treatment for esophageal cancer, inability to provide consent, recent participation in other trials, and medical conditions preventing imaging completion are exclusionary.

Study focus: The trial determines whether USPIO-enhanced imaging provides better information about cancer spread to lymph nodes compared to standard imaging, both before and after initial cancer treatment. Participants receive single weight-based Ferrotran dose through intravenous infusion, then undergo MRI scanning twice—once before starting cancer treatment and once after completing it, with total participation lasting 2 days.

Investigational drugs: USPIO (Ultrasmall Superparamagnetic Iron Oxide) is a contrast agent injected into the bloodstream, enhancing lymph node visibility during MRI scans. The tiny iron particles are naturally processed by the body after imaging completion. Chemoradiotherapy combines chemotherapy drugs and radiation treatment given before surgery to help shrink tumors.

Study on the Safety of Radiation and Nivolumab for Patients with Esophageal Cancer

This trial evaluates the safety and feasibility of using nivolumab in combination with radiation therapy for treating esophageal cancer.

Main inclusion criteria: Participants must be older than 18 years with confirmed squamous cell carcinoma or adenocarcinoma by tissue sample. Different cohorts have specific requirements: Cohort A patients eligible for palliative fractionated radiotherapy with expected survival over 3 months; Cohort B eligible for definitive chemoradiation for localized but inoperable cancer; Cohort C eligible for neoadjuvant chemoradiotherapy and surgery. Patients need ECOG performance status of 0 or 1, adequate organ function, negative pregnancy tests for women of childbearing potential, and agreement to use contraception. Signed informed consent and cooperation with treatment and follow-up are required.

Main exclusion criteria: Patients with other cancer types besides esophageal cancer, those with severe side effects from similar treatments, abnormal blood test results, unstable vital signs, poor performance status unable to carry out daily activities, and vulnerable populations unable to give consent cannot participate.

Study focus: The study monitors safety by observing side effects and changes in health indicators including blood tests and vital signs. It assesses how well treatment can be carried out and patient responses, evaluating overall survival, cancer response both within and outside radiated areas, and for some participants, measuring time lived without cancer worsening after surgery. Quality of life is evaluated using questionnaires, with the trial continuing until end of 2025.

Investigational drugs: Nivolumab is immunotherapy medication administered through intravenous infusion, helping the immune system recognize and attack cancer cells by blocking proteins preventing immune response. Irradiation uses high-energy rays similar to X-rays to damage cancer cell DNA, stopping growth and division, often used to shrink tumors and improve symptoms.

Summary

The 19 ongoing clinical trials for oesophageal carcinoma reflect a diverse research landscape exploring multiple treatment approaches. A significant concentration of trials is found in the Netherlands, which hosts 7 studies, followed by France, Spain, and Denmark. Several trials are multinational, particularly those studying immunotherapy combinations.

Immunotherapy features prominently across many trials, with pembrolizumab and nivolumab being the most frequently studied agents. Multiple trials investigate combining immunotherapy with chemotherapy or targeted therapies, reflecting the current trend toward combination approaches. HER2-targeted therapies appear in several studies, highlighting the importance of molecular characteristics in treatment selection.

The trials span the disease spectrum from post-surgical settings to advanced metastatic disease, with different studies focusing on specific patient populations including elderly patients and those with particular molecular markers. Some studies explore supportive care interventions such as infection prevention after surgery and nutritional recovery. Trial designs range from early-phase dose-finding studies to larger comparative effectiveness trials, indicating ongoing efforts to both develop new treatments and optimize existing approaches.

Ongoing Clinical Trials on Oesophageal carcinoma

  • Study of Durvalumab with Chemotherapy and Radiotherapy for Patients with Unresectable Esophageal Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Aspirin’s Effect on Recurrence and Survival in Patients with Non-Metastatic Breast, Colon, Rectal, Stomach, Esophageal, and Prostate Cancer

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Ireland

  • Study on Pembrolizumab, Lenvatinib, and Belzutifan for Patients with Liver, Colon, Pancreatic, Bile Duct, Gallbladder, Endometrial, or Esophageal Cancer

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France The Netherlands Spain

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