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)
Sponsor study identifier
interventional
70
1 country
1
Study Start
January 17, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 28, 2024
Actual (reported)January 7, 2025
Actual (reported)January 17, 2025
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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).
chemotherapy includes SOX and XELOX
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Cancer Hodpital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021, China
LIN YANG, Doctor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First Submitted
December 28, 2024
First Posted
January 7, 2025
Study Start
January 17, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 21, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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