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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retlirafusp alfa Injection, Capecitabine, Oxaliplatin, Sintilimab or Tislelizumab (based on investigator's choice).
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
Interventions
- Drug Retlirafusp alfa Injection
Retlirafusp alfa injection,1800mg, Q3w - Drug Capecitabine
Capecitabine, Q3W - Drug Oxaliplatin
Oxaliplatin, Q3W - Drug Sintilimab or Tislelizumab (based on investigator's choice)
Sintilimab or Tislelizumab, Q3w - Drug Capecitabine
Capecitabine, Q3W - Drug Oxaliplatin
Oxaliplatin, Q3W
Primary outcome measures
- Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1 [Time frame: Up to 2 years]
Secondary outcome measures (5)
- Overall survival (OS) [Time frame: Up to approximately 5 years]
- Objective response rate (ORR) based on investigator assessment according to RECIST 1.1 [Time frame: Up to 2 years]
- Disease control rate (DCR) based on investigator assessment according to RECIST 1.1 [Time frame: Up to 2 years]
- Duration of response (DoR) based on investigator assessment according to RECIST 1.1 [Time frame: Up to 2 years]
- Adverse events (AEs). [Time frame: Up to approximately 5 years]
Eligibility criteria
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, 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. 5. 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07677293 · MA- GC-III-034