A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) Cancer
NCT05216237 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2022-04-11
Summary
To evaluate the efficacy and safety of Sintilimab combined with apatinib and chemotherapy as First-line or second-line Therapy in Treatment of HER-2 negative MSS Advanced or Metastatic GC or GEJ Cancer. At the same time, the correlation between tissue programmed death ligand-1(PD-L1) expression and blood circulating tumor cell(CTC) counts and the efficacy of immune combination therapy was also explored.
Conditions
- Gastric Cancer
- Chemotherapy
- Immunotherapy
Interventions
- DRUG
-
Sintilimab 200 mg, intravenously (IV) every 3 weeks(Q3W)
for 2-6 cycles followed by Sindilizumab plus Tegafur gimeracil oteracil potassium capsules.
Sponsors & Collaborators
-
Lanzhou University Second Hospital
collaborator OTHER -
Jiuda Zhao
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-15
- Primary Completion
- 2024-06-01
- Completion
- 2025-06-01
Countries
- China
Study Locations
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