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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
• Intervention / Treatment: Drug: SHR-1701; Drug: S-1; Drug: Paclitaxel; Drug: Capecitabine; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yanan Zheng; Phone Number: +8613636404065; Email: ianzyn@163.com

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    • Contact: Yanan Zheng; Phone Number: +8613636404065; Email: ianzyn@163.com
    • Principal Investigator: Yanan Zheng
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Changhai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1	Drug: SHR-1701; SHR-1701, 1800mg, Q3w; Drug: S-1; S-1, Q3W; Drug: Paclitaxel; Paclitaxel,Q3W
Experimental: SHR-1701 and CAPOX	Drug: SHR-1701; SHR-1701, 1800mg, Q3w; Drug: Capecitabine; Capecitabine, Q3W; Drug: Oxaliplatin; Oxaliplatin, Q3W

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
2-year overall survival rate	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event free survival (EFS)		Up to 2 years
AEs		Up to approximately 18 months
Conversion surgery rate		Up to 4 weeks after completion of surgery
R0 resection rate		Up to 4 weeks after completion of surgery
Pathological complete response(pCR)		Up to 4 weeks after completion of surgery
Tumor regression grade		Up to 4 weeks after completion of surgery
DFS	Disease-free survival (DFS)	Up to 2 years
Overall survival(OS)		Up to 3 years

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Principal Investigator: Yanan Zheng, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleic Acids, Nucleotides, and Nucleosides; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Coordination Complexes; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Nucleosides; Uracil; Pyrimidinones; Deoxyribonucleosides; Fluorouracil; Capecitabine; Oxaliplatin; Paclitaxel; SHR-1701; S 1 (combination)
• Other Study ID Numbers: MA-GC-II-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No