IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

January 10, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2029

Conditions
Nasopharyngeal CarcinomaImmune Checkpoint InhibitorRadiotherapyChemotherapy
Interventions
RADIATION

Intensity Modulated Radiation Therapy

All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions.

DRUG

Chemotherapy

Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles

BIOLOGICAL

Immune checkpoint inhibitor

Cadonilimab: 10mg/kg, Q3W, 3 cycles

RADIATION

Low-dose radiotherapy

Low-dose radiotherapy will be performed to study group, with the use of IMRT.

Trial Locations (3)

Unknown

Cancer Center, Sun Yat-sen University, Guangzhou

The First Affiliated Hospital of Guangxi Medical University, Nanning

Jiangxi Cancer Hospital, Nanchang

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT05941741 - IC Plus Low-dose Radiation Plus Cadonilimab in LANPC | Biotech Hunter | Biotech Hunter