Nab-TPC vs GP Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT06669611
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nasopharyngeal Cancinoma (NPC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab combined GP chemotherapy — DRUG
    Camrelizumab was intravenously given at dose of 200 mg on day 1. The GP regimen included gemcitabine administered at a dose of 1 g/m2 on day 1 and day 8, cisplatin at a dose of 80 mg/m2 on day 1.Q3W 1 cycle, 4-6 cycles.
  • Camrelizumab combined TPC chemotherapy — DRUG
    Camrelizumab was intravenously given at dose of 200 mg on day 1. The TPC regimen included nab-paclitaxel administered at a dose of 200 mg/m2 on day 1, cisplatin at a dose of 60 mg/m2 on day 1, and capecitabine at a dose of 1000 mg/m2, taken orally twice a day on days 1 to 14, for each cycle. Q3W 1 cycle, 4-6 cycles.

Study Details

We expect to conduct a clinical trial in recurrent and metastatic nasopharyngeal carcinoma patients to explore and compare the efficacy and safety of induction chemotherapy (TPC vs. GP) with combination therapy of Camrelizumab.

Key Dates

Start date
Nov 27, 2024
Status verified
Dec 2024
Primary completion
Nov 20, 2027
Completion
Nov 20, 2029

Study Design

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

Arms

  • Active Comparator: Camrelizumab with GP chemotherapy
    Camrelizumab, cisplatin and gemcitabine
  • Experimental: camrelizumab with nab-TPC chemotherapy
    camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine)

Primary Outcome Measure

Progression-Free Survival [ Time Frame: 15 months ]

Central Contacts