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RECRUITING
NCT07392320
PHASE2

A Phase II Trial Comparing Immunotherapy Versus Capecitabine Maintenance After Chemo-chemoradiotherapy for High-risk Nasopharyngeal Carcinoma

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

In this study, the investigators designed a randomized, open-label, phase II clinical trial for high-risk locally advanced nasopharyngeal carcinoma (T4 or N3 or EBV DNA ≥1500 copies/ml, AJCC 9th edition) that is sensitive to chemotherapy and PD-1 monoclonal antibody therapy. The trial compares sequential treatment with the TP regimen combined with PD-1 monoclonal antibody followed by concurrent chemoradiotherapy and PD-1 maintenance therapy versus capecitabine maintenance therapy. The aim is to provide high-quality clinical evidence for optimizing the treatment strategy for high-risk locally advanced nasopharyngeal carcinoma.

Official title: A Randomized, Open-Label, Phase II Clinical Study Comparing Immunotherapy Combined With Induction Chemotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy Maintenance Versus Capecitabine Maintenance in Locally Advanced High-Risk Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-02-04

Completion Date

2033-02-04

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

TP+PD1+CCRT

Induction Chemoimmunotherapy (3 cycles, Q3W): Induction chemotherapy consisted of three cycles of docetaxel (75 mg/m², day 1), cisplatin (75 mg/m², day 1), and penpulimab (200 mg, day 1), administered every 3 weeks. Concurrent Chemotherapy (3 weeks post-induction, 2 cycles, Q3W): concurrent cisplatin 100mg/m2 every 21days for two cycles during Intensity modulated-radiotherapy (IMRT)

DRUG

PD-1 Monoclonal Antibody

Penpulimab 200 mg every 3 weeks for 8 cycles

DRUG

Capecitabine

Capecitabine 1000 mg/m² BID, days 1-14, for 8 cycles.

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China