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IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

NCT05941741 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Nasopharyngeal Carcinoma
  • Immune Checkpoint Inhibitor
  • Radiotherapy
  • Chemotherapy

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Chong Zhao, MD, PhD · Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05941741 on ClinicalTrials.gov