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Toripalimab Combined With Chemotherapy as Neoadjuvant Treatment of Gastric Cancer

NCT04119622 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-03-11

No results posted yet for this study

Summary

Gastric cancer (GC) is one of the most common malignancies. According to the global cancer statistics 2018, there were 1,033,701 new cases of gastric cancer per year, ranked the fifth place in new tumors, and 782,685 deaths, ranked the second place in cancer deaths. At present, surgery is the only way to cure gastric cancer, but the 5-year survival rate is only 20%-30%. studies have confirmed that neoadjuvant therapy could improve the R0 resection rate and overall survival, which is considered a better treatment strategy.

PD 1 monoclonal antibody is definitely effective in neoadjuvant therapy in other tumors such as NSCLC and bladder cancer, especially in PD-L1+ patients. However, there is no research of PD-1 monoclonal antibody in neoadjuvant therapy of gastric cancer. Thus we plan to conduct this prospective phase II clinical trial, evaluating the safety and efficacy of toripalimab, also known as JS001, in combination with XELOX for the neoadjuvant therapy of gastric cancer.

Conditions

  • Gastric Cancer Stage II
  • Gastric Cancer Stage III

Interventions

DRUG

capecitabine

apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles

DRUG

Toripalimab

toripalimab 240 mg d1; q3w, up to two cycles.

DRUG

oxaliplatin

oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles

Sponsors & Collaborators

  • Aiping Zhou

    lead UNKNOWN

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
2019-10-08
Primary Completion
2022-09-30
Completion
2024-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04119622 on ClinicalTrials.gov