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

Sponsor
Sun Yat-sen University
Study ID
NCT05854849
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — DRUG
    200mg, D1, Q3W, iv drip.
  • Gemcitabine — DRUG
    1000mg/m2, Day 1 and Day 8, Q3W, iv drip, maximum 6 cycles.
  • Cisplatin — DRUG
    80 mg/m2, D1, Q3W, iv drip, maximum 6 cycles.
  • Apatinib — DRUG
    250mg, PO, QD

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
May 2023
Primary completion
Dec 1, 2025
Completion
Dec 1, 2027

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GAP
  • Active Comparator: GPP

Primary Outcome Measure

Progression-free survival [ Time Frame: 2 years ]

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