Ongoing Clinical Trials for Gastroesophageal Cancer
There are currently 14 clinical trials studying new treatments for gastroesophageal cancer across Europe. These studies are testing various combinations of immunotherapy, chemotherapy, and targeted therapies to improve outcomes for patients with this disease. Trials are taking place in multiple countries, including Germany, France, Spain, Italy, and others, offering patients access to innovative treatment approaches.
Clinical trial locations
- Austria
- Study on Sertraline with Immunochemotherapy for Patients with Advanced Gastroesophageal Cancer
- Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
- Study on Regorafenib and Nivolumab for Patients with Advanced Gastro-Oesophageal Cancer
- Belgium
- Czechia
- Denmark
- Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer
- Study on [68Ga]Ga-FAPI-46 PET/CT Imaging for Better Diagnosis in Patients with Pancreatic and Gastroesophageal Cancer
- Study on 68Ga-FAPI-46 and Fludeoxyglucose (18F) for Diagnosing Stomach and Gastroesophageal Junction Cancer in Patients Undergoing Chemotherapy
- Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer
- France
- Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal Cancer
- Study on Reducing Chemotherapy for Patients with Low-Risk Localized Gastroesophageal Cancer Using Docetaxel, Oxaliplatin, Calcium Folinate, and Fluorouracil
- Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer
- Germany
- Study of Bemarituzumab with Irinotecan, Paclitaxel, Ramucirumab, or Trifluridine/Tipiracil for Advanced Stomach or Gastroesophageal Cancer in Patients After Chemotherapy
- Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal Cancer
- Study on Organ Preservation for Early Stage Esophageal Cancer Using Durvalumab and Chemoradiation for Patients Eligible for Surgery
- Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
- Study of Pembrolizumab, Trastuzumab, and Drug Combination for Patients with HER2-Positive, Localized Esophagogastric Cancer
- Study on Atezolizumab with Drug Combination for Patients with Gastric Cancer and Esophagogastric Junction Adenocarcinoma
- Study on Regorafenib and Nivolumab for Patients with Advanced Gastro-Oesophageal Cancer
- Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer
- Ireland
- Italy
- Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal Cancer
- Study of Simvastatin with Nivolumab and Oxaliplatin for Patients with Advanced Stomach or Esophageal Cancer with ARID1A Mutation
- Study on Regorafenib and Nivolumab for Patients with Advanced Gastro-Oesophageal Cancer
Study of Bemarituzumab with Irinotecan, Paclitaxel, Ramucirumab, or Trifluridine/Tipiracil for Advanced Stomach or Gastroesophageal Cancer in Patients After Chemotherapy
This trial is testing a medication called Bemarituzumab in combination with standard cancer treatments for patients with advanced stomach or gastroesophageal cancer. The cancer must have a specific protein marker called FGFR2b.
Main inclusion criteria: Patients must be 18 years or older with FGFR2b-positive advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction. They must have received at least one previous treatment and have good organ function and an ECOG performance status of 0 or 1.
Main exclusion criteria: Patients without FGFR2b-positive cancer, pregnant or breastfeeding women, and those who have recently participated in another clinical trial or have allergies to the study medications.
Trial focus: The study aims to evaluate how well Bemarituzumab works when combined with Irinotecan, Paclitaxel with Ramucirumab, or Trifluridine/Tipiracil. Participants will be divided into different treatment groups, receiving either medication combinations or placebo for up to 12 months. The goal is to determine if these combinations can shrink the cancer or stop its growth.
Investigational drugs: Bemarituzumab targets the FGFR2b protein on cancer cells. It is combined with standard chemotherapy drugs including Irinotecan, Paclitaxel, Ramucirumab, and Trifluridine/Tipiracil, each working through different mechanisms to fight cancer.
Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer
This imaging study tests whether a new scanning method using [68Ga]Ga-FAPI-46 can provide better pictures of cancer than standard methods for patients with pancreatic or gastroesophageal cancer.
Main inclusion criteria: Patients must be 18 years or older, able to read and understand Danish, and have either suspected pancreatic cancer suitable for surgery or confirmed cancer of the lower esophagus, gastroesophageal junction, or stomach that can be surgically removed.
Main exclusion criteria: Patients without pancreatic or gastroesophageal cancer, those outside the specified age range, and vulnerable populations.
Trial focus: The study compares [68Ga]Ga-FAPI-46 PET/CT imaging to standard CT or MRI scans. Patients receive an injection of the tracer and undergo scans within 30 minutes and possibly again at 60 minutes to assess how well it detects cancerous lesions.
Investigational drugs: [68Ga]Ga-FAPI-46 is a radioactive tracer that attaches to proteins commonly found in cancer cells, making them visible on PET/CT scans. This helps doctors better locate and measure the extent of cancer.
Study on MK-2870, Pembrolizumab, and Chemotherapy for Patients with Advanced Gastroesophageal Cancer
This trial evaluates the safety and effectiveness of combining MK-2870 (sacituzumab tirumotecan) with pembrolizumab and chemotherapy for patients with advanced gastroesophageal adenocarcinoma.
Main inclusion criteria: Patients must be 18 years or older with locally advanced, unresectable, or metastatic gastroesophageal adenocarcinoma that is not HER2/neu positive. They must not have received prior systemic treatment and have adequate organ function and an ECOG performance status of 0 or 1.
Main exclusion criteria: Patients with other cancer types, those who have had previous treatment, and vulnerable populations.
Trial focus: The study tests different combinations of MK-2870 with pembrolizumab and various chemotherapy drugs including capecitabine, fluorouracil, oxaliplatin, and calcium folinate. The treatments are given through intravenous infusion and oral tablets to assess safety, tolerability, and effectiveness.
Investigational drugs: MK-2870 targets specific proteins on cancer cells, pembrolizumab helps the immune system fight cancer by blocking the PD-1 protein, and chemotherapy drugs work by killing rapidly dividing cancer cells.
Study on Organ Preservation for Early Stage Esophageal Cancer Using Durvalumab and Chemoradiation for Patients Eligible for Surgery
This study explores whether combining durvalumab with chemoradiation can help preserve the esophagus in patients with early-stage esophageal adenocarcinoma, potentially avoiding radical surgery.
Main inclusion criteria: Patients must be 18 years or older with T1-T2N0 esophageal adenocarcinoma that is surgically removable. They must not have received prior treatment, have good organ function, an ECOG score of 0 or 1, and weigh more than 30 kg.
Main exclusion criteria: Patients with other cancer types, previous treatment for this cancer, serious health conditions including severe heart or lung disease, pregnant or breastfeeding women, and those with HIV, hepatitis, or autoimmune diseases.
Trial focus: Participants receive durvalumab as an immunotherapy along with chemotherapy drugs including docetaxel, oxaliplatin, calcium folinate, and fluorouracil through intravenous infusion. An endoscopic re-evaluation assesses treatment effectiveness, with long-term monitoring up to three years.
Investigational drugs: Durvalumab blocks the PD-L1 protein to enhance immune system recognition of cancer cells, while chemoradiation combines chemotherapy and radiation therapy to kill cancer cells and enhance treatment effectiveness.
Study on Sertraline with Immunochemotherapy for Patients with Advanced Gastroesophageal Cancer
This Austrian trial investigates whether adding sertraline, a commonly used antidepressant, to standard immunochemotherapy can improve treatment response in advanced gastroesophageal cancer.
Main inclusion criteria: Patients must be 18 years or older with confirmed diagnosis of gastric, gastroesophageal junction, or esophageal adenocarcinoma. They should have measurable disease, plan to receive first-line palliative immunochemotherapy with FOLFOX/CAPOX and nivolumab, and have ECOG-PS 0-2 with adequate organ function.
Main exclusion criteria: Patients with different cancer types, those outside the age range, inability to receive standard treatment, serious health conditions, pregnancy or breastfeeding, inability to give informed consent, recent participation in other trials, and allergies to study medications.
Trial focus: Participants receive sertraline as 50 mg tablets in addition to standard immunochemotherapy. The study monitors treatment response, progression-free survival, overall survival, side effects, quality of life, and depression scales.
Investigational drugs: Sertraline is a selective serotonin reuptake inhibitor (SSRI) typically used for depression and anxiety. Researchers are testing whether it can enhance the effectiveness of cancer treatment by potentially influencing cancer treatment response.
Study on the Safety and Effectiveness of Trastuzumab Deruxtecan with Drug Combination for Patients with HER2+ Resectable Esophagogastric Cancer
This trial tests trastuzumab deruxtecan combined with chemotherapy before and after surgery for patients with HER2-positive esophagogastric adenocarcinoma.
Main inclusion criteria: Patients must be 18 years or older with locally advanced, resectable, HER2-positive esophagogastric adenocarcinoma. They must have an ECOG performance status of 0 or 1, adequate organ function, and no prior systemic anti-cancer therapy or partial/complete tumor removal.
Main exclusion criteria: Patients without HER2-positive cancer, those with non-resectable disease, serious heart problems, uncontrolled infections, pregnant or breastfeeding women, and those unable to follow study procedures.
Trial focus: Treatment includes trastuzumab deruxtecan along with fluorouracil, calcium folinate pentahydrate, and oxaliplatin through intravenous infusion. Following treatment, surgery is performed to remove the tumor, with continued medication afterward. Regular monitoring assesses safety and effectiveness.
Investigational drugs: Trastuzumab deruxtecan is an antibody-drug conjugate that targets HER2 protein on cancer cells, delivering chemotherapy directly to the tumor to inhibit cancer cell growth while minimizing damage to healthy cells.
Study of Simvastatin with Nivolumab and Oxaliplatin for Patients with Advanced Stomach or Esophageal Cancer with ARID1A Mutation
This Italian trial studies whether adding simvastatin, a cholesterol-lowering drug, to standard treatment can improve outcomes for patients with advanced gastroesophageal cancer that has an ARID1A mutation.
Main inclusion criteria: Patients must be 18 years or older with advanced or metastatic, HER2-negative, ARID1A-mutated gastroesophageal carcinoma. They should have measurable disease, life expectancy over 12 weeks, adequate organ function including bone marrow, liver, and kidneys, and ECOG Performance Status of 1 or less. Prior surgery for the primary tumor is allowed, but no other prior treatments.
Main exclusion criteria: Patients with different cancer types, inability to receive standard treatment with nivolumab plus oxaliplatin-based chemotherapy, pregnancy or plans to become pregnant, unacceptable side effects from similar treatments, and medical conditions making participation unsafe.
Trial focus: Treatment includes simvastatin tablets combined with nivolumab and oxaliplatin-based chemotherapy administered intravenously. Additional medications include fluorouracil, calcium levofolinate pentahydrate, and capecitabine. Regular monitoring assesses disease progression, treatment response, and quality of life over up to 60 weeks.
Investigational drugs: Simvastatin inhibits an enzyme involved in cholesterol production, which may also affect cancer cell growth. Nivolumab is an immunotherapy that helps the immune system fight cancer. Oxaliplatin-based chemotherapy damages cancer cell DNA to stop their growth and division.
Study on [68Ga]Ga-FAPI-46 PET/CT Imaging for Better Diagnosis in Patients with Pancreatic and Gastroesophageal Cancer
This Danish imaging study evaluates whether [68Ga]Ga-FAPI-46 PET/CT scans provide better diagnostic information than standard imaging for pancreatic and gastroesophageal cancer.
Main inclusion criteria: Patients must be 18 years or older and able to read and understand Danish. For Group A: suspected pancreatic cancer with no distant metastases and suitable for curative surgery. For Group B: confirmed carcinoma of the lower esophagus, gastroesophageal junction, or stomach that is operable and resectable.
Main exclusion criteria: Patients without pancreatic or gastroesophageal cancer, those outside the age range, and vulnerable populations.
Trial focus: After receiving an intravenous injection of [68Ga]Ga-FAPI-46 tracer, patients undergo total body PET/CT scans within 30 minutes and possibly at 60 minutes. Results are compared to standard imaging to evaluate sensitivity and accuracy in detecting cancerous lesions.
Investigational drugs: [68Ga]Ga-FAPI-46 is a radiopharmaceutical tracer that targets fibroblast activation protein commonly overexpressed in cancer tissues, allowing better visualization of tumors on PET/CT scans to improve diagnostic accuracy.
Study on Reducing Chemotherapy for Patients with Low-Risk Localized Gastroesophageal Cancer Using Docetaxel, Oxaliplatin, Calcium Folinate, and Fluorouracil
This French trial examines whether patients with low-risk gastroesophageal adenocarcinoma can safely receive less chemotherapy after surgery compared to the standard treatment.
Main inclusion criteria: Patients must be 18 years or older with non-metastatic adenocarcinoma of the stomach, esophagus, or gastroesophageal junction. They must have completed 4 cycles of preoperative FLOT chemotherapy, had successful surgery with complete tumor removal, low risk of recurrence (no lymph node involvement), ECOG Performance Status of 0 or 1, adequate organ function, and be able to start treatment within 10 weeks of surgery.
Main exclusion criteria: High-risk patients, those who haven’t completed required preoperative chemotherapy, incomplete tumor removal, and metastatic cancer.
Trial focus: Participants are randomly assigned to either surveillance without additional chemotherapy (de-escalation group) or standard post-operative chemotherapy with docetaxel, oxaliplatin, calcium folinate, and fluorouracil given intravenously. The study monitors 3-year overall survival and disease-free survival rates.
Investigational drugs: FLOT chemotherapy includes fluorouracil, leucovorin, oxaliplatin, and docetaxel, which work together to shrink tumors and eliminate remaining cancer cells. The study tests whether surveillance alone is as effective as continued chemotherapy for low-risk patients.
Study of Nivolumab or Placebo for Patients with Removed Esophageal or Gastroesophageal Junction Cancer
This large multicenter trial tests whether nivolumab can prevent cancer recurrence in patients who have had surgery to remove Stage II or III esophageal or gastroesophageal junction cancer after receiving preoperative chemoradiotherapy.
Main inclusion criteria: Patients must have had adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction at Stage II or III. They must have completed preoperative chemoradiotherapy followed by surgery that successfully removed all visible cancer, though some cancer cells may remain. Both male and female patients are eligible.
Main exclusion criteria: Details not fully specified, but the trial uses placebo control and double-blind design.
Trial focus: Participants are randomly assigned to receive either nivolumab or placebo as intravenous infusions. Neither patients nor researchers know which treatment is given. The study monitors disease-free survival (time before cancer returns) and overall survival.
Investigational drugs: Nivolumab is an immune checkpoint inhibitor that blocks the PD-1 receptor on T-cells, enhancing the immune system’s ability to recognize and attack any remaining cancer cells after surgery.
The trial is taking place in multiple European countries including France, Ireland, Romania, Poland, Denmark, Czechia, Belgium, Germany, Spain, and the Netherlands, providing broad access to this potentially important treatment approach.
Summary
The 14 ongoing clinical trials for gastroesophageal cancer demonstrate diverse approaches to improving patient outcomes. A notable concentration of trials is taking place in Germany, which hosts 8 studies, followed by multiple trials in France, Denmark, and other European countries. This geographic distribution provides patients across Europe with access to innovative treatments.
Several key trends emerge from these trials. Immunotherapy combinations are prominent, with multiple studies testing drugs like nivolumab, pembrolizumab, durvalumab, and atezolizumab alongside chemotherapy. HER2-positive cancers are specifically targeted in several trials using trastuzumab-based therapies. Advanced imaging techniques using tracers like [68Ga]Ga-FAPI-46 are being evaluated to improve diagnostic accuracy, particularly in Denmark.
The trials address different disease stages, from early-stage localized disease where organ preservation is being explored, to advanced and metastatic disease where new drug combinations are tested. Some studies focus on specific genetic markers, such as FGFR2b-positive or ARID1A-mutated cancers, representing a move toward personalized medicine approaches.
Interestingly, one trial is investigating sertraline, traditionally an antidepressant, for its potential to enhance immunochemotherapy effectiveness, representing an innovative approach to repurposing existing medications. Treatment de-escalation is also being studied in low-risk patients to reduce treatment burden while maintaining effectiveness.
