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RECRUITING
NCT06811844
PHASE2

Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for LANPC

Sponsor: The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

Summary

This prospective, phase II, multicenter, randomized controlled study aims to compare the complete response rate and long-term survival outcomes of two-cycle and three-cycle induction therapy with modified TPF regimens combined with camrelizumab in patients with locally advanced nasopharyngeal carcinoma.

Official title: Comparison of Two-cycle and Three-cycle Induction Therapy With Modified TPF Regimen Combined and Camrelizumab for Locally Advanced Nasopharyngeal Carcinoma: A Prospective, Phase II, Multicenter, Randomized Controlled Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2025-02-25

Completion Date

2029-12-31

Last Updated

2025-07-01

Healthy Volunteers

No

Interventions

DRUG

Two-cycle induction chemotherapy + immunotherapy

Two cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.

DRUG

Three-cycle induction chemotherapy + immunotherapy

Three cycles of nab-paclitaxel at 260 mg/m2 on day 1, cisplatin at 25 mg/m2 from days 1 to 3, and oral S1 twice daily from days 1 to 14 (40 mg twice daily on patients with a body surface area \[BSA\] less than 1.25 m2, 50 mg twice daily for patients with a BSA between 1.25 and 1.5 m2, and 60 mg twice daily for patients with a BSA \>1.5 m2). Camrelizumab was administered intravenously at a dose of 200 mg on the first day of each cycle.

Locations (3)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Zhangzhou Affiliated Hospital of Fujian Medical University

Zhangzhou, Fujian, China

Hainan General Hospital

Haikou, Hainan, China