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Oesophageal adenocarcinoma – Trials in Disease

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Ongoing Clinical Trials for Oesophageal Adenocarcinoma

There are currently 38 clinical trials investigating new treatments for oesophageal adenocarcinoma. These studies are testing various approaches including targeted therapies, immunotherapies, and combination treatments across multiple countries worldwide. The trials focus on different stages of the disease, from early resectable cancer to advanced metastatic disease, offering hope for improved outcomes through innovative treatment strategies.

Clinical trial locations

Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

This trial investigates the combination of Disitamab Vedotin and Tucatinib for patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma. Participants must be at least 18 years old with a confirmed diagnosis that has progressed after standard treatments. The main exclusion criteria include patients who have received certain prior cancer treatments.

The study focuses on determining the optimal dose of Disitamab Vedotin when combined with Tucatinib and evaluating the safety and tolerability of these treatments. Disitamab Vedotin is administered as an intravenous infusion, while Tucatinib is taken orally as a tablet. The trial explores how these treatments perform across different groups of patients, including those with varying HER2 protein levels.

Throughout the study, participants are closely monitored for side effects and cancer response. The research aims to assess whether this combination can control or reduce cancer more effectively than existing treatments, potentially offering a new therapeutic option for patients with these aggressive cancer types.

Study of JK06 for Patients with Advanced or Metastatic Cancer

This trial tests JK06, a novel antibody-drug conjugate, in patients with unresectable locally advanced or metastatic cancer, including gastroesophageal adenocarcinoma. Participants must be at least 18 years old with adequate organ function and must agree to undergo tumor biopsies. Women of childbearing potential must use reliable contraception.

The study aims to determine the safest and most effective dose of JK06 through two phases: dose escalation and dose expansion. JK06 is administered through intravenous infusion every three weeks. The medication works by targeting specific proteins on cancer cells and delivering a toxic substance directly to them.

Throughout the trial, participants are monitored for side effects and tumor response. The study evaluates progression-free survival, overall survival, and the objective response rate. This research may provide insights into developing JK06 as a treatment option for patients with these challenging cancer types.

Study of MK-2870 for Patients with Advanced or Metastatic Stomach Cancer, Comparing Its Effects to a Drug Combination

This trial compares MK-2870 with physician-chosen treatments for patients with advanced gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma. Participants must have confirmed TROP2-positive status and have received at least two prior therapies. The cancer must be HER2 negative with measurable disease according to medical guidelines.

The study evaluates whether MK-2870 can improve overall survival compared to standard treatments. Participants receive treatment through intravenous infusion or oral tablets, depending on their assigned group. Alternative treatment options include trifluridine-tipiracil, paclitaxel, docetaxel, or irinotecan.

Regular monitoring assesses treatment effectiveness and side effects. The trial aims to provide valuable data on whether MK-2870 offers a more effective treatment approach for patients who have exhausted standard therapy options for these aggressive cancer types.

Study of Oxaliplatin, Nivolumab, and Trifluridine/Tipiracil for Patients with Advanced Gastric, Esophageal, or Gastroesophageal Junction Cancer

This French trial compares different treatment combinations for HER2-negative gastric, esophageal, or gastroesophageal junction adenocarcinoma. Patients must be at least 18 years old with adequate organ function and ECOG performance status of 0 or 1. The cancer must be metastatic, unresectable, and have at least one measurable lesion.

The study evaluates whether trifluridine/tipiracil combined with oxaliplatin, with or without nivolumab, can delay cancer progression better than the FOLFOX regimen with or without nivolumab. Participants are randomly assigned to treatment groups and monitored throughout the trial.

Treatment is administered in cycles, with regular assessments of disease progression and side effects. The research aims to identify more effective treatment strategies for patients with these advanced cancer types who often have limited therapeutic options.

Study of zolbetuximab, pembrolizumab and chemotherapy in adults with HER2-negative, Claudin 18.

This multicountry trial investigates zolbetuximab combined with pembrolizumab and chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma expressing CLDN18.2 and PD-L1. Participants must be at least 18 years old with good physical functioning (ECOG 0 or 1) and a life expectancy of at least 12 weeks.

The study tests whether adding zolbetuximab to standard treatment improves outcomes. Treatment includes intravenous infusions of zolbetuximab and pembrolizumab, combined with chemotherapy drugs (capecitabine or oxaliplatin, fluorouracil, and folinic acid). Some chemotherapy is taken orally.

Regular monitoring evaluates treatment response and side effects. The trial aims to determine whether this combination therapy provides better results than standard treatment alone for patients with specific molecular markers in their tumors.

Study on [18F]FAPI-74 for Better Cancer Imaging in Patients with Esophagogastric and Pancreatic Cancer

This Belgian imaging study evaluates [18F]FAPI-74 PET/CT scanning for detecting oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma. Participants must be at least 18 years old with confirmed cancer diagnosis. Women of childbearing potential require a negative pregnancy test within 24 hours before receiving the imaging agent.

The study compares this new imaging method with standard techniques like [18F]FDG PET/CT. The imaging agent is administered through injection and helps visualize cancer-associated fibroblasts, potentially improving cancer detection accuracy.

Regular assessments monitor safety and evaluate whether this new imaging approach provides superior cancer detection compared to conventional methods. The research could lead to improved diagnostic capabilities and better treatment planning for these cancer types.

Study on Adding Trastuzumab and Pertuzumab to Treatment for Patients with Resectable HER2 Positive Esophageal Cancer

This Dutch trial investigates adding trastuzumab and pertuzumab to standard chemoradiotherapy before surgery for HER2-positive esophageal adenocarcinoma. Participants must have surgically resectable cancer at specific stages (T1N+M0 or T2-T4a N0 or N+M0) with HER2-positive status confirmed by local and central laboratories.

The study evaluates whether these targeted medications can improve overall survival when added to standard treatment. Both trastuzumab and pertuzumab are administered through intravenous infusion and work by targeting the HER2 protein on cancer cells.

Participants must be at least 18 years old with adequate heart, blood, kidney, and liver function. Regular monitoring assesses treatment response, side effects, and quality of life. The research aims to determine whether this combination approach offers better outcomes than standard treatment alone.

Study on AZD0901 and Drug Combination for Patients with Advanced Gastric, Gastroesophageal, and Pancreatic Cancers Expressing Claudin 18.2

This study tests AZD0901 alone and combined with other cancer medications for CLDN18.2-positive gastric, gastroesophageal junction, and pancreatic cancers. Participants must be at least 18 years old with confirmed diagnosis and positive CLDN18.2 expression. They must have received at least two prior treatments for advanced disease.

The trial evaluates safety, tolerability, and preliminary effectiveness of AZD0901. Treatment is administered through intravenous infusion, with possible combinations including irinotecan, folinic acid, gemcitabine, and fluorouracil.

Regular monitoring assesses tumor response, side effects, and overall survival. The study aims to identify optimal dosing and determine whether AZD0901 provides a beneficial treatment option for patients with these CLDN18.2-expressing cancers who have limited alternatives.

Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal

This multicountry trial investigates budesonide orodispersible tablets for preventing esophageal strictures after endoscopic submucosal dissection. Participants must be between 18 and 85 years old with ECOG performance status of 2 or less after the procedure. Women of childbearing potential must have negative pregnancy tests and use effective contraception.

The study compares different budesonide doses with placebo over eight weeks. Budesonide is an effervescent tablet that dissolves in the mouth. The treatment aims to prevent narrowing of the esophagus that can occur after cancer tissue removal.

Regular follow-up assessments evaluate the percentage of patients remaining free of strictures and the need for endoscopic dilation procedures. The research could provide a new approach to preventing this common complication after cancer treatment.

Study on Gallium (68Ga) Tezatabep Matraxetan PET for Evaluating HER2 Status in Patients with Gastro-Esophageal and HER2-Low Breast Cancer

This Swedish imaging study evaluates 68Ga-ABY-025 PET/CT scanning for assessing HER2 status in gastroesophageal cancer and HER2-low breast cancer. Participants must be at least 18 years old with confirmed metastatic disease and WHO performance status of 0 or 1. Life expectancy must be at least 12 weeks.

The study compares this imaging technique with standard methods to evaluate HER2 protein levels in tumors and metastases. The imaging agent is administered through injection, helping visualize HER2-expressing cancer cells.

Regular assessments monitor the accuracy and clinical utility of this imaging approach. The research aims to improve HER2 status evaluation, potentially leading to better treatment selection and monitoring for patients with these cancer types.

Summary

The 38 clinical trials for oesophageal adenocarcinoma demonstrate a strong focus on combination therapies and personalized medicine approaches. Trials are concentrated primarily in Western European countries, particularly Germany, France, Spain, Italy, Belgium, and the Netherlands, with some extending to Eastern Europe and Scandinavia.

Several common themes emerge across the trials. Many studies investigate immunotherapy combinations, particularly using pembrolizumab, nivolumab, or durvalumab with chemotherapy. Targeted therapies focusing on specific biomarkers are prominent, with multiple trials examining HER2-targeted treatments (trastuzumab, pertuzumab), CLDN18.2-targeted therapies (zolbetuximab, AZD0901), and TROP2-targeted approaches (sacituzumab govitecan).

The trials span the full disease spectrum from early resectable disease to advanced metastatic cancer. Several studies focus on perioperative treatment strategies combining neoadjuvant and adjuvant therapies. Advanced imaging techniques using novel PET tracers are also being evaluated to improve cancer detection and treatment monitoring.

Most trials require good performance status (ECOG 0-1 or WHO 0-2) and adequate organ function. Many studies have specific biomarker requirements, emphasizing the shift toward precision medicine in oesophageal cancer treatment. The variety of approaches being tested offers hope for improved outcomes across different patient populations and disease stages.

Ongoing Clinical Trials on Oesophageal adenocarcinoma

  • A study comparing trifluridine, tipiracil, and fruquintinib versus trifluridine and tipiracil alone for patients with metastatic stomach or esophageal cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Spain

  • Study of Zolbetuximab combined with Paclitaxel and Ramucirumab for patients with previously treated CLDN18.

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study of zanidatamab with drug combination for patients with HER2 and PD-L1 positive advanced gastroesophageal cancer

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study on Metformin for Patients with Esophageal Cancer to Enhance Chemoradiotherapy Response

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Adding Trastuzumab and Pertuzumab to Treatment for Patients with Resectable HER2 Positive Esophageal Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Spain

  • Study of Disitamab Vedotin and Tucatinib for Patients with Advanced Breast Cancer or Gastric Cancer

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Spain

  • Study on the Effectiveness of Oxaliplatin, Docetaxel, and Fluorouracil in Patients with Resectable Gastric and Gastroesophageal Junction Cancer

    Recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of rilvegostomig, trastuzumab deruxtecan, and AZD0901 in patients with locally advanced resectable gastroesophageal cancer before and after surgery

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

  • Study on Reducing Chemotherapy for Patients with Low-Risk Localized Gastroesophageal Cancer Using Docetaxel, Oxaliplatin, Calcium Folinate, and Fluorouracil

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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