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

NCT04367025 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-04-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Camrelizumab

Camrelizumab: 200mg,iv drip for 1h,d1,q3w

DRUG

Oxaliplatin

Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;

DRUG

S1

S-1:40\~60mg Bid, d1\~14, q3w;

Sponsors & Collaborators

  • Chinese PLA General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-31
Primary Completion
2022-05-31
Completion
2023-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367025 on ClinicalTrials.gov