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A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer

NCT04152889 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-20

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) . Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR). Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer. To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.

Conditions

  • Gastric Cancer Stage III

Interventions

DRUG

Camrelizumab

Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

DRUG

S-1

Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.

DRUG

Docetaxel

Docetaxel: 40 mg/m\^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Gang Zhao · RenJi Hospital, Shanghai JiaoTong University, School of Medicine Shanghai, Shanghai, China, 200127

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-04-14
Primary Completion
2022-04-01
Completion
2022-12-31

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 NCT04152889 on ClinicalTrials.gov