SHR-1701 with chemotherapy for gastric/GEJ cancer with peritoneal spread

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, randomized trial in adults with gastric or GEJ adenocarcinoma and peritoneal metastasis. It compares two regimens: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, versus SHR-1701 with CAPOX. Eligible patients are newly diagnosed, ECOG 0-1, with peritoneal metastasis confirmed by laparoscopy or lavage, and no prior anti-tumor therapy. Exclusions include HER2 positivity, prior gastric cancer surgery, non-peritoneal metastases, and significant organ dysfunction. Primary aims focus on efficacy and safety of the regimens to inform future treatment options.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old.
2. Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).
3. 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.
4. No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
6. Normal function of major organs.

Exclusion Criteria:

1. Known HER2-positive.
2. Previous history of gastric cancer surgery.
3. Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.
4. Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).
5. Active autoimmune disease within 4 weeks prior to enrollment or a history of autoimmune disease.
6. Significant cardiovascular disease within 6 months prior to enrollment, including unstable angina or myocardial infarction.

Where it's running

• Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Yanan Zheng — Ruijin Hospital
• Study coordinator: Yanan Zheng
• Email: ianzyn@163.com
• Phone: +8613636404065

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.