Trials testing a treatment · 4 studies
Something new is being tried here: a medicine, a regimen or a procedure. If you join, you receive either the treatment under study or the standard one, and the team follows you closely.
First-line HER2-positive gastric or junction cancer: trastuzumab deruxtecan alongside chemotherapy, pembrolizumab and trastuzumab
This clinical trial is designed to assess the efficacy and safety of the triplet combination of trastuzumab deruxtecan (ENHERTU, T-DXd, DS-8201a) plus a fluoropyrimidine plus pembrolizumab versus standard of care (SoC) chemotherapy plus trastuzumab plus pembrolizumab as first-line therapy in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS ≥1 gastric or GEJ cancer in the Main Cohort. An Exploratory Cohort will also be evaluated to assess the efficacy and safety of T-DXd plus a fluoropyrimidine versus SoC chemotherapy plus trastuzumab in participants with unresectable, locally advanced or metastatic HER2-positive tumor PD-L1 CPS \<1 gastric or GEJ cancer.
For: Gastric Cancer, Gastroesophageal Junction Cancer
6 centres: Institutul Clinic Fundeni, București · Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca, Cluj-Napoca · Centrul de Oncologie Sfantul Nectarie Craiova, Craiova · and 3 more
Phase 3See the official record ↗NCT06731478
Original registry title
Study of TDXd, Chemotherapy, Pembrolizumab, and Trastuzumab in First-Line Metastatic HER2-Positive Gastric or Gastroesophageal Junction Cancer
Advanced gastric or junction cancer: zolbetuximab and pembrolizumab added to chemotherapy
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.
The main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.
Adults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People can also take part if they need to take medicines like steroids to suppress their immune system. They cannot take part if they have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.
For: Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
6 centres: Site RO40008, București · Site RO40001, Cluj-Napoca · Site RO40003, Craiova · and 3 more
Phase 3See the official record ↗NCT06901531
Original registry title
A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer
HER2-positive gastric or junction cancer: HLX22 added to trastuzumab and chemotherapy
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
For: Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
5 centres: Regional Institute of Gastroenterology and Hepatology, Cluj-Napoca · Clinica Amethyst Radiotherapy, Craiova · Centrul de Oncologie Sfantu Nectarie, Florești · and 2 more
Phase 3See the official record ↗NCT06532006
Original registry title
A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer
Untreated advanced gastric, junction or oesophageal cancer: a new medicine with chemotherapy compared with nivolumab with chemotherapy
The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma
For: Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma
4 centres: Institutul Regional de Gastroenterologie și Hepatologie Prof. Dr. Octavian Fodor, Cluj-Napoca · Centrul de Oncologie "Sfântul Nectarie", Craiova · SC Radiotherapy Center Cluj SRL, Florești · and 1 more
Phase 2See the official record ↗NCT07221149
Original registry title
A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)
Observational studies · 2 studies
You do NOT receive a new treatment here. You have your usual care, and researchers collect information about how it goes. Useful for people after you, but it does not change your own care.
Observational registry: outcomes of endoscopic resection for digestive-tract tumours
This is a patient registry for all cases of pre-neoplastic or early neoplastic digestive tract lesions treated with curative intention by endoscopic submucosal dissection (ESD) technique.
For: Neoplasm, Stomach, Neoplasm, Colorectal, Neoplasm, Esophagus, Neoplasm, Duodenal
One centre: "Agrippa Ionescu" Hospital, București
Phase not statedSee the official record ↗NCT06033976
Original registry title
Endoscopic Submucosal Dissection Registry
Observational study: screening for and treating H. pylori infection in young adults
Gastric cancer remains a major challenge to public health on a global scale. H. pylori related cancer burden contributes to the largest proportion of cancer cases attributable to infections in Europe. Considering its absolute burden and persisting disparities, in addition to the substantial prevalence of H. pylori infection worldwide that is treatable, gastric cancer is a logical target for urgent action for prevention. Population-based H. pylori test-and-treat has therefore been proposed as a strategy for gastric cancer prevention. To fill the gaps in knowledge about gastric cancer prevention through H. pylori screening and eradication in younger adults, a study of a population-based H. pylori test-and-treat strategy in Ireland, Croatia, Latvia, Poland, Romania and Slovenia.
Main goals of this study are to assess future program processes, feasibility, acceptability and effectiveness. In total of 6,800 adults aged 30-34 will be tested for H. pylori infection. They will be randomly selected to represent the chosen population and invited to participate in the study based on informed consent. Confirmed infections will be treated by available combined therapy in line with treatment guidelines and the success of eradication will be retested during a control check-up.
Patients who will provide their consent to participate will undertake an interview about the risk factors in early childhood and their habits regarding alcohol consumption and use of tobacco. Compliance to testing and treatment, treatment results, adverse effects and reasons for dropping out will be additionally monitored. Gathered data will be analysed in alignment with our research questions. The investigators will disseminate reports and present the results to both the general public and the scientific community in order to foster future developments in gastric cancer prevention.
For: Gastric Cancer, H Pylori Infection, H Pylori Eradication, H-pylori
One centre: Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
Phase not statedSee the official record ↗NCT06275204
Original registry title
H. Pylori Screen-and-treat Study in a Population of Young Adults
Source: ClinicalTrials.gov, the public registry of the US National Library of Medicine. Data retrieved on 15 Sept 2026.
