A Study of SHR-1210 in Combination With Capecitabine + Oxaliplatin or Apatinib in Treatment of Advanced Gastric Cancer

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT03472365
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHR-1210 — BIOLOGICAL
    SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
  • Capecitabine — DRUG
    1000 mg/m\^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
  • Oxaliplatin — DRUG
    130 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle.
  • Apatinib — DRUG
    375 mg administered as continuous oral once daily (QD) of each 3-week cycle.

Study Details

The purpose of this trial is to estimate overall response rate (ORR) of SHR-1210 combined with capecitabine and oxaliplatin or with apatinib as first-line treatment in subjects with locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Key Dates

Start date
Apr 2, 2018
Status verified
Apr 2023
Primary completion
Nov 25, 2020
Completion
Nov 25, 2020

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus capecitabine 1000 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days, plus oxaliplatin 130 mg/m\^2, IV q3w; for 4-6 cycles followed by SHR-1210 plus apatinib 375 mg PO qd if there is no PD.
  • Experimental: Cohort 2
    Participants receive SHR-1210 200 mg, intravenously (IV) every 3 weeks(Q3W) plus apatinib 375 mg daily (QD) continuous oral administration of each 3-week cycle.

Primary Outcome Measure

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: Up to approximately 6 months. ]

Related Studies