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A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

StatusActive, Not Recruiting
PhasePhase 3
Started2021-12-06
View on ClinicalTrials.gov ↗

Amendment history

2025-03-28
Study Status v7
Primary completion dateestimated 2025-03-15→confirmed 2024-05-20
Completion date2025-06-30→2025-10-01
2024-08-21
Study Status, Outcome Measures v6
Secondary endpoints11 to 17 entries
DCR in part 1 study PFS in part 2 study DCR in part 2 study DoR in part2 study PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1 ORR in part 2 study DCR in part 2 study
Primary endpoints3 entries, revised
OS in all subjects in part 2 study PFSOverall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study assessed based on BICR
2024-08-16
Study Status, Study Design v5
Enrollment targetestimated 738→confirmed 737
2024-08-15
Study Status, Study Design v4
Enrollment target737→738
2024-02-06
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v3
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 690→confirmed 737
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2022-09-01
Study Status, Study Design, Arms and Interventions, Eligibility v2
Enrollment target920→690
InterventionsPlacebo、CAPOX/FOLFOX (Drug), SHR-1701、CAPOX/FOLFOX (Drug)→Placebo、CAPOX (Drug), SHR-1701、CAPOX (Drug)
Eligibility criteria+17 characters
[...] known or suspected autoimmune disease. Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD1 [...]
2021-12-14
Not Yet Recruiting→Recruiting Study Status, Arms and Interventions, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-09-15→confirmed 2021-12-06
Study sites0→1
2021-07-01
Original filing
This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.
Trial Details
NCT Number NCT04950322
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Gastric or Gastroesophageal Junction Cancer
Enrollment 737 participants
Start Date 2021-12-06
Primary Completion 2024-05-20 (estimated)
Study Completion 2025-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-30