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Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT03707509 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 263

Last updated 2022-07-01

No results posted yet for this study

Summary

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Camrelizumab

Maximum 6 cycles for combined therapy. Camrelizumab maintenance.

DRUG

Placebos

Maximum 6 cycles for combined therapy.

DRUG

Gemcitabine

Maximum 6 cycles for combined therapy.

DRUG

Cisplatin

Maximum 6 cycles for combined therapy.

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Li Zhang, MD · Cancer Center of Sun-Yat Sen University (CCSYSU)

  • Qing Yang, MD · Jiangsu HengRui Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2021-08-01
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 NCT03707509 on ClinicalTrials.gov