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NCT Number: NCT07384234

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changhai Hospital, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1701

Drug

SHR-1701, 1800mg, Q3w

Capecitabine

Drug

Capecitabine, Q3W

S-1

Drug

S-1, Q3W

paclitaxel

Drug

Paclitaxel,Q3W

Oxaliplatin

Drug

Oxaliplatin, Q3W

Primary outcomes

  1. 2-year overall survival rate

    Time frame: Up to 2 years

Secondary outcomes

  1. Conversion surgery rate

    Time frame: Up to 4 weeks after completion of surgery

  2. R0 resection rate

    Time frame: Up to 4 weeks after completion of surgery

  3. Pathological complete response(pCR)

    Time frame: Up to 4 weeks after completion of surgery

  4. Tumor regression grade

    Time frame: Up to 4 weeks after completion of surgery

  5. Event free survival (EFS)

    Time frame: Up to 2 years

  6. DFS

    Time frame: Up to 2 years

    Disease-free survival (DFS)

  7. Overall survival(OS)

    Time frame: Up to 3 years

  8. AEs

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Yanan Zheng

CONTACT

[email protected]

+8613636404065

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis: an Exploratory Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 3, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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