NCT07677293尚未招募3 期
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 个研究点目标入组 332 人开始时间: 2026年6月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 332
- 主要终点
- Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Retlirafusp alfa Group
Experimental
干预措施: Retlirafusp alfa Injection (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
干预措施: Sintilimab or Tislelizumab (based on investigator's choice) (Drug)
Retlirafusp alfa Group
Experimental
干预措施: Oxaliplatin (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
干预措施: Capecitabine (Drug)
Retlirafusp alfa Group
Experimental
干预措施: Capecitabine (Drug)
Investigator's choice of anti-PD-1 antibody Group
Active Comparator
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS) based on investigator assessment according to RECIST 1.1
时间窗: Up to 2 years
次要结局
- 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)
研究者
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