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SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis | Clinical Trials | Clareo Health

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SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis

SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: A Randomized, Two-Cohort Study

NCT07384234•Ruijin Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Key Dates

Start Date

January 31, 2026

Primary Completion Date

December 30, 2028

Completion Date

December 30, 2030

Last Updated

February 3, 2026

Enrollment

ESTIMATED participants

Conditions

Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Interventions

SHR-1701

DRUG

Capecitabine

DRUG

S-1

DRUG

Paclitaxel

DRUG

Oxaliplatin

DRUG

Contacts

Yanan Zheng

CONTACT

+8613636404065 ianzyn@163.com