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Gemcitabine and Camrelizumab Plus Apatinib Versus Cisplatin in First-line Treatment of RM-NPC

NCT05854849 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2023-05-11

No results posted yet for this study

Summary

This study aims to explore a new, more effective and tolerable treatment regimen for patients with advanced recurrent/metastatic nasopharyngeal carcinoma. Specifically, we plan to conduct a phase III randomized controlled clinical trial based on the standard treatment of "GP + PD-1 mAb", replacing cisplatin with apatinib to achieve "platinum-free" therapy and reduce toxicity. In addition, we will investigate the efficacy of using apatinib in combination with PD-1 mAb compared to PD-1 mAb monotherapy to further improve treatment outcomes. The ultimate goal is to provide a new and reliable treatment modality for patients with advanced recurrent/metastatic nasopharyngeal carcinoma and guide clinical practice.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DRUG

Camrelizumab

200mg, D1, Q3W, iv drip.

DRUG

Gemcitabine

1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.

DRUG

Cisplatin

80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.

DRUG

Apatinib

250mg, PO, QD

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-12-01
Completion
2027-12-01

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 NCT05854849 on ClinicalTrials.gov