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

Phase 3

Recruiting

• Conditions: Nasopharyngeal Cancinoma (NPC)
• Interventions: Drug: Camrelizumab combined TPC chemotherapy; Drug: Camrelizumab combined GP chemotherapy

• Registration Number: NCT06669611
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

The therapeutic effect of patients with metastatic nasopharyngeal carcinoma has been further improved. Numerous previous studies have shown that anti-PD-1 immune checkpoint inhibitors (ICIs) have strong activity in treated metastatic nasopharyngeal carcinoma patients, with an objective response rate (ORR) of 20-34%. In addition, immunotherapy has also achieved good results in the first-line treatment of recurrent/metastatic nasopharyngeal carcinoma. In 2021, the clinical results of a study on the treatment of recurrent/metastatic nasopharyngeal carcinoma with pembrolizumab were published. The median PFS of the pembrolizumab combined with chemotherapy group was 9.7 months, significantly prolonging PFS, with an HR value of 0.54, and reducing the risk of disease progression by 46%. Based on this, the 2022 CSCO guidelines will use pembrolizumab combined with GP chemotherapy as a new first-line treatment for metastatic nasopharyngeal carcinoma.We conducted a study comparing the efficacy of GP regimen and nab TPC regimen, and found that nab TPC regimen significantly improved the survival of patients with metastatic nasopharyngeal carcinoma compared to GP regimen, and the nab TPC regimen group had milder grade 3-4 toxic side effects.This study aims to design a prospective phase III clinical trial on the safety and efficacy of GP combined with Carilizumab compared to nab TPC regimen combined with Carilizumab chemotherapy for recurrent and metastatic nasopharyngeal carcinoma

Study Timeline

• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-01
• Study Start: 2024-11-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2027-11-20
• Study Completion: 2029-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
camrelizumab with nab-TPC chemotherapy	Camrelizumab combined TPC chemotherapy	camrelizumab plus nab-TPC chemotherapy (nab-paclitaxel, cisplatin and capecitabine)
Camrelizumab with GP chemotherapy	Camrelizumab combined GP chemotherapy	Camrelizumab, cisplatin and gemcitabine

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	15 months	The primary endpoint was PFS, which was assessed as the time from randomization to disease progression per RECIST v1.1 assessed by IRC or death, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Safety and Adverse Events	3 months	Adverse events occurring during chemotherapy
Overall Survival	1,3,5 years	The secondary endpoint was OS, which was assessed as the time from randomization to death according to RECIST v1.1 or PERCIST, whichever occurred first.

Trial Locations

Locations (1)

SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China