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

A Phase II Study of Sintilimab Combined With Chemotherapy as Postoperative Adjuvant Treatment for Phase III Gastric Adenocarcinoma (GC) and The Adenocarcinoma of Esophagogastric Junction (GEJ)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Adenocarcinoma; Esophagogastric Junction Adenocarcinoma
• Intervention / Treatment: Biological: Sintilimab plus Chemotherapy

Detailed Description

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 that meets the criteria for group entry and does not meet the exclusion criteria. After signing the informed consent, the subjects entered the trial group to receive adjuvant treatment with Sintilimab combined with chemotherapy (SOX or XELOX ), in which SOX or XELOX chemotherapy was up to 8 cycles, and the total course of treatment was 16 cycles. The efficacy is evaluated every 4 cycles during the study treatment. The frequency of follow-up after treatment is defined as: once every 3 months within 2 years after surgery, every 6 months for 2 to 5 years, and once a year after 5 years. The follow-up interval can be adjusted according to the clinical need. Safety follow-up is from the beginning of the first treatment to 30 days after the last medication.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: LIN YANG, Doctor; Phone Number: 010-13681015148; Email: linyangcicams@126.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: LIN YANG; Phone Number: 010-13681015148; Email: linyangcicams@126.com
      • Principal Investigator: LIN YANG, Doctor

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sintilimab + SOX/XELOX; 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; chemotherapy includes SOX and XELOX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
DFS	disease free survival	From the time of first dose of adjuvant treatment to the time when the subjects have confirmed disease progress
overall survival (OS)	overall survival	From the time of first dose of adjuvant treatment to the time when the subjects have died for all causes
safety	treatment safety and adverse events	collect all adverse events since the last medication up to 30 days

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: LIN YANG, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Therapeutics; Drug Therapy; sintilimab
• Other Study ID Numbers: NCC4947

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