Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody P… (NCT07677293) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy as First-line Treatment for Advanced Gastric Cancer With Liver Metastases
332 participantsStarted 2026-06-26
Plain-language summary
This study is a randomized, controlled, open-label phase III clinical trial, aims to compare the efficacy and safety of Retlirafusp alfa injection plus CAPOX versus the investigator's choice of anti-PD-1 antibody plus CAPOX as first-line treatment in patients with advanced gastric cancer (GC) or gastroesophageal junction cancer (GEJC) with liver metastases
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age ≥ 18 years; 2. Patients with recurrent or previously untreated advanced gastric or gastroesophageal junction cancer with liver metastases, histopathologically confirmed as adenocarcinoma.
3\. No prior systemic therapy (including anti-HER2 therapy) for advanced or metastatic GC/GEJC. Patients who have received prior adjuvant or neoadjuvant therapy are eligible provided that the time from completion of last therapy to first recurrence or disease progression is \> 6 months.
4\. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
6\. Adequate organ and bone marrow function. 7. Female subjects of non-childbearing potential are defined as those who are postmenopausal, or have undergone documented hysterectomy and/or bilateral oophorectomy. Male subjects and female subjects of childbearing potential must agree to use at least one medically approved contraceptive method during the study and for 120 days after the last dose of study treatment. A serum pregnancy test must be negative within 3 days prior to the start of study treatment, and subjects must not be breastfeeding.
8\. Voluntarily signed informed consent, and willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
Exclusion Criteria:
* 1\. Known gastric cancer of squamous cell carcinoma, undifferen…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1