Efficacy and Safety of TPC+Apatinib+Camrelizumab vs GP+ Camrelizumab for High-Risk Nasopharyngeal Carcinoma: A Phase 3 Trial

Sponsor
XIANG YANQUN
Study ID
NCT06438627
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study aims to evaluate the efficacy and safety of the TPC regimen (nab-paclitaxel, cisplatin, and capecitabine) combined with apatinib and camrelizumab versus the GP regimen (gemcitabine and cisplatin) combined with camrelizumab for the treatment of high-risk regionally advanced nasopharyngeal carcinoma with a high risk of distant metastasis. The evaluation will be conducted through a prospective, controlled, open-label, multicenter phase 3 clinical trial in areas with high incidence of nasopharyngeal carcinoma.

Key Dates

Start date
May 30, 2024
Status verified
Jul 2024
Primary completion
May 30, 2026
Completion
May 30, 2029

Study Design

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

Arms

  • Experimental: TPC+Apatinib+Camrelizumab
    Radiation: IMRT Drug: Nab-Paclitaxel, Cisplatin, and Capecitabine Chemotherapy Combined With Apatinib and Camrelizumab (Induction chemotherapy)
  • Active Comparator: GP+ Camrelizumab
    Radiation: IMRT Drug: Gemcitabine, Cisplatin Combined With Camrelizumab (Induction chemotherapy)

Primary Outcome Measure

3-years FFS [ Time Frame: up to 3 years ]

Central Contacts

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