Efficacy and Safety of Perioperative Chemotherapy Plus PD-1 Antibody in Gastric Cancer

Sponsor
Chinese PLA General Hospital
Study ID
NCT04367025
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    Camrelizumab: 200mg,iv drip for 1h,d1,q3w
  • Oxaliplatin — DRUG
    Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;
  • S1 — DRUG
    S-1:40\~60mg Bid, d1\~14, q3w;

Study Details

For locally advanced gastric cance, neoadjuvant chemotherapy can increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. Camrelizumab（SHR-1210） in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma and Hepatocellular carcinoma. This study is a single center, open-label, randomized comparative phase II clinical trial to evaluate safety and efficacy of Camrelizumab in combination with perioperative chemotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Differences in T cell expression were detected by single cell RNA sequencing to screen people who were more sensitive to immunotherapy.

Key Dates

Start date
May 31, 2020
Status verified
Apr 2020
Primary completion
May 31, 2022
Completion
May 31, 2023

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: SOX
    SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Neoadjuvant chemotherapy for 2-4 cycles, adjuvant chemotherapy for 2-4 cycles
  • Experimental: Camrelizumab+ SOX
    Camrelizumab:200mg,iv drip for 1h,d1,q3w SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40\~60mg Bid, d1\~14, q3w; Neoadjuvant chemotherapy+ Camrelizumab for 2-4 cycles, adjuvant chemotherapy + Camrelizumab for 2-4 cycles.

Primary Outcome Measure

Major pathologic response (MPR) [ Time Frame: At time of surgery ]

Central Contacts

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