SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
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: SHR-1701, Capecitabine, S-1, Paclitaxel.
- 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
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: an Exploratory Study
Overview
This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.
Interventions
- Drug SHR-1701
SHR-1701, 1800mg, Q3w - Drug Capecitabine
Capecitabine, Q3W - Drug S-1
S-1, Q3W - Drug Paclitaxel
Paclitaxel,Q3W - Drug Oxaliplatin
Oxaliplatin, Q3W
Primary outcome measures
- 2-year overall survival rate [Time frame: Up to 2 years]
Secondary outcome measures (8)
- Conversion surgery rate [Time frame: Up to 4 weeks after completion of surgery]
- R0 resection rate [Time frame: Up to 4 weeks after completion of surgery]
- Pathological complete response(pCR) [Time frame: Up to 4 weeks after completion of surgery]
- Tumor regression grade [Time frame: Up to 4 weeks after completion of surgery]
- Event free survival (EFS) [Time frame: Up to 2 years]
- DFS [Time frame: Up to 2 years]
- Overall survival(OS) [Time frame: Up to 3 years]
- AEs [Time frame: Up to 3 years]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years old.
- Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
- Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.
- No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- Normal function of major organs.
Exclusion criteria
- Known HER2-positive.
- Previous history of gastric cancer surgery.
- Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
- Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
- Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
- Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.
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
China · 2 centers
- Changhai Hospital — Shanghai
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai
Identifiers
NCT: NCT07384234 · MA-GC-II-026