Sintilimab Combined With Chemotherapy as Adjuvant Treatme... | NCT06761846

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

NCT06761846

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Recruiting

Last Update Posted

Apr 21, 2026Actual

Enrollment

70Estimated

Phase

Phase 2

Conditions

Gastric Adenocarcinoma
Esophagogastric Junction Adenocarcinoma

Interventions

Sintilimab plus Chemotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2025Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Dec 28, 2024

First Submission Date that Met QC Criteria

Jan 6, 2025

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2026

Last Update Posted Date

Apr 21, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

LIN YANG, Doctor, Cancer Institute and Hospital, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Sintilimab plus Chemotherapy	Biological	chemotherapy includes SOX and XELOX	Sintilimab + SOX/XELOX

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LIN YANG, Doctor	Contact	010-13681015148		linyangcicams@126.com

Overall Officials

Name	Affiliation	Role
LIN YANG, Doctor	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College	Recruiting	Beijing	Beijing Municipality	100021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
C000632826	sintilimab
D004358	Drug Therapy