A Randomized, Double-Blind, Multi-Center Phase II/III Clinical Study of PD-L1 Antibody/TGF-βRII (SHR-1701) Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer

Suzhou Suncadia Biopharmaceuticals Co., Ltd.20 sites in 1 country81 target enrollmentJanuary 26, 2022

ConditionsPerioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer

InterventionsSHR-1701 injection Placebo

DrugsSHR-1701 injection Placebo

Overview

Phase: Phase 2
Intervention: SHR-1701 injection
Conditions: Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 81
Locations: 20
Primary Endpoint: Phase II : Pathological Complete Response pCR rate.
Status: Terminated
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate.

Stage II is a randomized, double-blind, multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC. A total of 846 treatment naïve subjects will be enrolled, and primary endpoint of this stage is Independent Review Committee (IRC)-assessed EFS.

Registry

clinicaltrials.gov

Start Date

January 26, 2022

End Date

April 3, 2024

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically diagnosed with GC or GEJC, histologically confirmed to be adenocarcinoma, and have no previous anti-tumor treatments for GC or GEJC.
•Aged 18 or above, male or female.
•Be suitable for (investigator's assessment) and planning to undergo neoadjuvant therapy + radical surgery with curative intent before entering into the study.
•locally advanced Gastric Cancer or Gastroesophageal Junction Cancer confirmed by investigator.
•Be able to provide tumor tissue blocks.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
•Life expectancy of ≥ 6 months.
•Have adequate organ and bone marrow functions.
•Women without childbearing potential refer to post-menopausal women, or women who underwent bilateral oophorectomy with medical records. Male subjects and female subjects of childbearing potential must agree to take a medically approved contraceptive measure (refer to Appendix 4) during the study, within 3 months after the last dose of investigational product (SHR-1701), and within 9 months after the last dose of chemotherapy agents (S-1 and oxaliplatin); have a negative serum pregnancy test result within 3 days prior to the start of study treatment and not be breastfeeding.
•Subjects must agree and have signed the informed consent form, be willing and able to follow the scheduled visits, study treatment, laboratory tests, and other study procedures.

Exclusion Criteria

•Have known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with gastric cancer of other histological types.
•Have unresectable factors, including unresectable tumors or contraindications to surgery or refusal of surgery.
•Have more than 20% weight loss within 2 months prior to enrollment or randomization.
•Have previously received some treatments or medications including anti-tumor treatments.
•Diagnosed with other malignant tumors within 5 years prior to enrollment.
•Have any active, known, or suspected autoimmune disease.
•Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment or randomization; have gastrointestinal perforation and/or gastrointestinal fistula within 6 months prior to enrollment or randomization; have arterial/venous thrombotic events within 6 months prior to enrollment or randomization.
•Have major vascular disease within 6 months prior to enrollment or randomization.
•Have severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
•Have intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment or randomization.

Arms & Interventions

SHR-1701 + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

Intervention: SHR-1701 injection

Placebo + Tegafur Gimeracil Oteracil Potassium and Oxaliplatin

Intervention: Placebo

Outcomes

Primary Outcomes

Phase II : Pathological Complete Response pCR rate.

Time Frame: Up to approximately 23 months

pCR rate is defined as the proportion of subjects whose specimens (including primary lesion and lymph nodes) obtained during GC or GEJC radical surgery are pathologically assessed to be free of residual live tumor cells after neoadjuvant therapy.

Phase III : Event-free Survival (EFS)

Time Frame: Up to approximately 57 months

EFS is defined as time from randomization to PD or death (whichever occurs first), detailed that tumor progression/recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.

Secondary Outcomes

30-day postoperative mortality.(Up to approximately 24 months)
Overall Survival (OS).(Up to approximately 57 months)
Disease-free Survival (DFS).(Up to approximately 57 months)
Preoperative Objective Response Rate (ORR).(Up to approximately 57 months)
Percentage of Participants Who Experience One or More Adverse Events (AEs).(Up to approximately 57 months)
Major pathological response (MPR) rates.(Up to approximately 23 months)
R0 resection rate(Up to approximately 23 months)