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NOT YET RECRUITING
NCT07540390
PHASE3

RCT of GAPP Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced NPC.

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

Summary

The investigators have designed a multicenter, open-label, randomized controlled phase III clinical study of GAPP induction therapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (stage III, AJCC 9th edition). The aim is to obtain high-level, high-quality evidence-based data to clarify the efficacy and safety of combining chemoradiotherapy with PD-1 antibody and anlotinib, thereby providing a new treatment strategy to improve the prognosis of patients with high-risk locoregionally advanced nasopharyngeal carcinoma. In this study, GPP induction chemotherapy followed by concurrent chemoradiotherapy and toripalimab maintenance therapy is selected as the control group. This regimen is currently the standard treatment recommended by guidelines for high-risk locoregionally advanced nasopharyngeal carcinoma, with well-established efficacy and broad clinical application. It provides a reliable benchmark for comparing the efficacy and safety of the experimental group, meets ethical requirements, and has mature clinical operational procedures.

Official title: An Open-label, Multicenter, Randomized Controlled Phase III Clinical Trial of PD-1 Monoclonal Antibody Plus Anlotinib Combined With Induction and Concurrent Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

442

Start Date

2026-05-08

Completion Date

2032-12-31

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

Toripalimab

Toripalimab, 240 mg per administration, on Day 1, diluted in 100 mL of normal saline, administered as an intravenous infusion over 30 minutes (no less than 20 minutes and no more than 60 minutes). After the toripalimab infusion, there should be an interval of 30-60 minutes before administering gemcitabine and cisplatin. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 9 cycles will be administered.

DRUG

Anlotinib

Anlotinib, 8 mg per dose per day, once daily on Days 1-14, taken orally before breakfast. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.

DRUG

Cisplatin

Cisplatin, with a treatment cycle of 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 5 cycles will be administered.

DRUG

Gemcitabine

Gemcitabine, 1000 mg/m², on Days 1 and 8, diluted in 500 mL of 0.9% normal saline, administered as an intravenous infusion. Each treatment cycle is 21 days. If the subject's toxicity recovery does not meet the criteria for the next cycle of chemotherapy, the start of the next cycle may be appropriately delayed, but the delay should not exceed 21 days. A total of 3 cycles will be administered.

RADIATION

radiation

IMRT

Locations (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, China