RecruitingPhase 3NCT06669611

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

Nab-TPC Versus GP Chemotherapy Combined With Camrelizumab in the Treatment of Recurrent/Metastatic Nasopharyngeal Carcinoma: Randomized Controlled, Multi Center, Phase III Clinical Study

Sponsor

Sun Yat-sen University

Enrollment

242 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

Age over 18 years.
ECOG score of 0-1.
Expected survival of at least 12 weeks.
Recurrent/Metastatic Nasopharyngeal Carcinoma.
At least 4 weeks since the previous chemotherapy.
At least one (according to RECIST) measurable lesion, lesions that have been previously irradiated can not be considered target lesions.
had adequate organ function

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Interventions

DRUGCamrelizumab combined GP chemotherapy

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.

DRUGCamrelizumab combined TPC chemotherapy

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.