NCT07384234

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
57mo left

Started Jan 2026

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Dec 2030

First Submitted

Initial submission to the registry

January 26, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 2-year overall survival rate

    Up to 2 years

Secondary Outcomes (8)

  • 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

  • Event free survival (EFS)

    Up to 2 years

  • +3 more secondary outcomes

Study Arms (2)

SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1

EXPERIMENTAL
Drug: SHR-1701Drug: S-1Drug: Paclitaxel

SHR-1701 and CAPOX

EXPERIMENTAL
Drug: SHR-1701Drug: CapecitabineDrug: Oxaliplatin

Interventions

SHR-1701DRUG

SHR-1701, 1800mg, Q3w

SHR-1701 and CAPOXSHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
CapecitabineDRUG

Capecitabine, Q3W

SHR-1701 and CAPOX
S-1DRUG

S-1, Q3W

SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
PaclitaxelDRUG

Paclitaxel,Q3W

SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
OxaliplatinDRUG

Oxaliplatin, Q3W

SHR-1701 and CAPOX

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Interventions

SHR-1701CapecitabineS 1 (combination)PaclitaxelOxaliplatin

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Yanan Zheng

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanan Zheng

CONTACT

+8613636404065ianzyn@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 3, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2030

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)