Actively Recruiting
An Open-label, Randomized, Comparative Phase III Study Including Patients With CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer
Led by Suzhou Immunofoco Biotechnology Co., Ltd · Updated on 2025-10-23
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have not responded to at least two prior treatments. The study aims to compare the objective response rate and progression-free survival of a new treatment called IMC002 against the investigator's choice of treatment as a third-line or later therapy. This is an open-label, randomized phase III trial designed to better understand treatment outcomes in this patient group. Participants will receive either IMC002 CAR-T cell therapy or a control treatment chosen by their investigator, which may include chemotherapy options. Treatment will be given after randomization, and the study will monitor patients over time to evaluate how well each treatment controls the cancer. The trial includes regular assessments to track tumor response and disease progression. During the study, participants will undergo scheduled evaluations including laboratory tests and imaging to measure tumor size and progression using RECIST 1.1 criteria. Researchers will monitor safety and efficacy outcomes such as progression-free survival up to 96 weeks after randomization. Patients will be followed to assess overall survival and treatment impact, with ongoing medical support and monitoring throughout the trial duration.
CONDITIONS
Brief Title
A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at randomization
- Histologically or cytologically confirmed inoperable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma
- Failed at least two prior lines of therapy including documented progression or intolerance
- Tumor tissue positive for CLDN18.2 expression (≥40% tumor cell rate and staining intensity ≥2+)
- Expected survival of at least 12 weeks
- At least one measurable or evaluable lesion per RECIST 1.1 with largest lesion diameter ≤5 cm
- ECOG performance status score of 0 or 1
- Adequate organ and bone marrow function meeting specified laboratory criteria
- Previous anti-tumor therapy toxicities resolved to Grade 0-1 or acceptable levels
- Willingness to use effective contraception for 12 months after cell infusion if of childbearing potential
- Signed informed consent
- Willing and able to comply with study treatment, tests, and follow-up requirements
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive tests for HIV, hepatitis B or C, syphilis, Epstein-Barr virus, cytomegalovirus, HTLV, or active COVID-19 infection
- Known HER2 positive status
- Active or uncontrolled serious infections
- Uncontrollable pleural, pericardial effusion, or ascites
- Extensive or diffuse lung, liver, or bone metastases
- Blood oxygen saturation ≤95% without oxygen
- Serious pulmonary diseases limiting study participation
- High risk of bleeding or perforation from tumor lesions
- Untreated or uncontrolled central nervous system diseases or metastases
- Unstable or poorly controlled heart disease or hypertension
- Recent myocardial infarction or significant heart conditions
- Significant bleeding risk or coagulopathy
- Recent use of systemic steroids or immunosuppressive drugs
- Active autoimmune diseases or history with expected recurrence
- Previous gene therapies including CAR-T or TCR-T
- Recent anti-tumor treatments within specified timeframes
- Severe allergies including anaphylaxis
- Severe mental disorders
- Participation in other interventional trials within 1 month
- Gastrointestinal obstruction or obstructive jaundice
- Other serious uncontrolled medical conditions as judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 96 weeks or until disease progression or discontinuation
Participants receive either CAR T cell therapy or chemotherapy as selected by their investigator to treat CLDN18.2-positive unresectable locally advanced gastric cancer.
Regular visits during treatment as per protocol
Duration - Up to 96 weeks after treatment
Participants are monitored for overall survival and safety after treatment completion.
Periodic visits for survival and safety assessments
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing
Beijing, China, 100853
Actively Recruiting
Research Team
J
Jianming Xu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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