NCT07677293Not yet recruitingPhase 3
Retlirafusp Alfa Injection Plus Chemotherapy Versus Investigator's Choice of Anti-PD-1 Antibody Plus Chemotherapy for Previously Untreated, Advanced Gastric or Gastroesophageal Junction Cancer With Liver Metastases: a Randomized, Controlled, Multicenter Phase III Clinical Study
Peking University0 sites332 target enrollmentStarted: June 26, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 332
- Primary Endpoint
- Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. Age ≥ 18 years;
- •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-
- •At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.
- •6. Adequate organ and bone marrow function.
- •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, undifferentiated carcinoma, or other histological types, or adenocarcinoma mixed with other histological types.
- •2. Untreated or inadequately treated central nervous system (CNS) metastases, or uncontrolled or symptomatic active CNS metastases.
- •3. Diagnosis of any other malignancy within 5 years prior to study entry, except for: skin basal cell carcinoma or squamous cell carcinoma that has been locally treated and documented as cured, superficial bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma, and other early-stage tumors with low risk of recurrence that have undergone curative treatment as judged by the investigator.
- •4. Presence of any active, known, or suspected autoimmune disease.
- •Prior treatment with TGF-β inhibitors, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, CTLA-4 antibodies, or other drugs/antibodies targeting T-cell costimulatory or checkpoint pathways.
- •6. Severe, non-healing, or dehiscent wound, or active ulcer, or untreated fracture.
- •7. Any other serious physical or mental illness, or laboratory abnormalities that may increase the risk of study participation, interfere with study results, or render the subject unsuitable for the study judged by the investigator.
Arms & Interventions
Retlirafusp alfa Group
Experimental
Intervention: Retlirafusp alfa Injection (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
Intervention: Sintilimab or Tislelizumab (based on investigator's choice) (Drug)
Retlirafusp alfa Group
Experimental
Intervention: Oxaliplatin (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
Intervention: Capecitabine (Drug)
Retlirafusp alfa Group
Experimental
Intervention: Capecitabine (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
Intervention: Oxaliplatin (Drug)
Outcomes
Primary Outcomes
Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1
Time Frame: Up to 2 years
Secondary Outcomes
- Objective response rate (ORR) based on investigator assessment according to RECIST 1.1(Up to 2 years)
- Disease control rate (DCR) based on investigator assessment according to RECIST 1.1(Up to 2 years)
- Duration of response (DoR) based on investigator assessment according to RECIST 1.1(Up to 2 years)
- Adverse events (AEs).(Up to approximately 5 years)
- Overall survival (OS)(Up to approximately 5 years)
Investigators
Similar Trials
Not yet recruiting
Not Applicable
Retlirafusp Alfa Injection Combined Chemotherapy for Perioperative Treatment of Esophagogastric Junction Adenocarcinoma: A Single-Arm, Phase II Study of Safety and EfficacyGEJ AdenocarcinomaNCT07493382Tianjin Medical University Cancer Institute and Hospital30
Not yet recruiting
Phase 2
Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction CancerGastric AdenocarcinomaNCT07610629Henan Cancer Hospital50
Not yet recruiting
Phase 2
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)NSCLCNCT07550920Tianjin Medical University Cancer Institute and Hospital18
Not yet recruiting
Not Applicable
A Phase II Study to Evaluate the Efficacy and Safety of Anti-HER2 Triple-targeted Drugs Combined With CDK4/6 Inhibitors in Neoadjuvant Therapy for ER-positive HER2-positive Breast Cancer Patients.Breast CancerNCT07290166Fudan University42
Recruiting
Phase 1
Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade GliomasAnaplastic OligodendrogliomaAstrocytoma, IDH-Mutant, Grade 3Astrocytoma, IDH-Mutant, Grade 4Diffuse AstrocytomaGlioblastoma, IDH-WildtypeMalignant GliomaNCT07468136Mayo Clinic33