SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
Recruiting now · Phase 2
Conditions studied: Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT07384234
- Run by
- Ruijin Hospital
- People needed
- 60
- Starts
- 2026-04-24
- Expected to finish
- 2030-12-30
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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