Sintilimab Combined With Chemotherapy as Adjuvant Treatment for Phase III GC and GEJ

NCT06761846 | Recruiting Phase 2

• 1 other identifier: NCC4947
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, phase II clinical study. Screening patients with stage III GC/GEJ adenocarcinoma after D2 or broader radical resection. After enrolling in the study, the subjects receive Sintilimab combined with oxaliplatin+Tegafur, Gimeracil and Oteracil Potassium Capsules (SOX) or oxaliplatin+Capecitabine (XELOX) , in which the combined chemotherapy is up to 8 cycles, and the total course of treatment was 16 cycles. The following-up of subjects includes adverse events、disease status、living conditions and the quality of life.

Conditions

Gastric Adenocarcinoma; Esophagogastric Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year disease free survival(DFS) rate

  The disease free survival rate of 3 years after receiving the first dose of treatment

  From the time of first dose of adjuvant treatment to the 3 years of the same day

Secondary Outcomes (3)

• DFS

  From the time of first dose of adjuvant treatment to the time when the subjects have confirmed disease progress

• overall survival (OS)

  From the time of first dose of adjuvant treatment to the time when the subjects have died for all causes

• safety

  collect all adverse events since the last medication up to 30 days

Study Arms (1)

Sintilimab + SOX/XELOX

EXPERIMENTAL

The study only has one experimental cohort that the subjects who enter the study will receive Sintilimab combined with SOX/XELOX up to 8 cycles, and then receive Sintilimab combined with Tegafur, Gimeracil and Oteracil Potassium Capsules or Capecitabine up to a year ( totally 16 cycles).

Biological: Sintilimab plus Chemotherapy

Interventions

Sintilimab plus Chemotherapy BIOLOGICAL

chemotherapy includes SOX and XELOX

Sintilimab + SOX/XELOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18.
• Patients with histopathological confirmed gastric/GEJ adenocarcinoma.
• The pTNM is confirmed between IIIA-IIIC and the PD-L1 CPS\>=1.
• Patients treated with D2 surgery.
• ECOG is 0 or 1.
• Patients who could tolerate chemotherapy combined with immunotherapy.
• Patients who are not pregnant and have no willing to get pregnant within 6 months after the treatment is over.
• Patients who are willing to offer their postoperative tumor tissue and their peripheral blood samples.
• Patients who are volunteer to sign the ICF.

You may not qualify if:

• Patients who had received neoadjuvent treatments before surgery.
• Patients who have discovered tumor relapse or metastasis before adjuvent treatment.
• Patients who have other malignant tumors.
• Patients who could not swallow the tablets and capsules.
• Other conditions which the researchers think are not suitable for participate the study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

sintilimab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• LIN YANG, Doctor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LIN YANG, Doctor

CONTACT

010-13681015148; linyangcicams@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 7, 2025
• Study Start: January 17, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)