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Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody) and Chemoradiotherapy in Locoregionally-advanced Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:
Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody) Combined With Chemoradiotherapy in High-risk Locoregionally-advanced Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial

Clinical Trial Summary

The trial aimed to compare cadonilimab combined with induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus IC+CCRT alone in high-risk locoregionally-advanced nasopharyngeal carcinoma (LANPC).

Clinical Trial Description

The trial plans to enroll patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Patients will be randomized in a 1:1 ratio to receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation or the same regimen plus cadonilimab in induction chemotherapy and adjuvant chemotherapy. All patients will receive intensity-modulated radiotherapy (IMRT). Cadonilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 3 cycles in induction therapy and for 14 cycles in adjuvant therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05587374
Study type Interventional
Source Sun Yat-sen University
Contact Jun Ma, M.D.
Phone +862087343469
Email majun2@mail.sysu.edu.cn
Status Recruiting
Phase Phase 3
Start date August 1, 2023
Completion date January 1, 2027
View Details
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