RecruitingPhase 3NCT05941741

IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial

Sponsor

Sun Yat-sen University

Enrollment

380 participants

Start Date

Jan 10, 2024

Study Type

INTERVENTIONAL

Conditions

Chemotherapy Radiotherapy Immune Checkpoint Inhibitor Nasopharyngeal Carcinoma

Summary

This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of induction chemotherapy, low-dose radiation, and an immunotherapy drug (cadonilimab) for locally advanced nasopharyngeal carcinoma (cancer at the back of the nasal cavity, a type common in Asia). **You may be eligible if...** - You are between 18 and 70 years old - You have a newly confirmed diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO type II or III) - Your cancer is at an advanced local stage (T4N1 or T1–4N2–3, no distant spread) - You are in good general health (ECOG 0–1) - You have not received any prior cancer treatment **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have already received chemotherapy, radiation, or immunotherapy - You have active autoimmune disease - You have other serious medical conditions that make this treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONIntensity 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.

DRUGChemotherapy

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

BIOLOGICALImmune checkpoint inhibitor

Cadonilimab: 10mg/kg, Q3W, 3 cycles

RADIATIONLow-dose radiotherapy

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