IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Phase 3

Active, not recruiting

• Conditions: Immune Checkpoint Inhibitor; Chemotherapy; Nasopharyngeal Carcinoma; Radiotherapy
• Interventions: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy; Biological: Immune checkpoint inhibitor; Radiation: Low-dose radiotherapy

• Registration Number: NCT05941741
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-01
• Study First Submitted QC: 2023-07-11
• Study First Posted: 2023-07-12
• Study Start: 2024-01-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
• All genders, range from 18-70 years old;
• ECOG score 0-1;
• Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th);
• Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
• No contraindications to chemotherapy, radiotherapy or immunotherapy;
• Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
• Sign the consent form.

Exclusion Criteria

• Distant metastases;
• Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
• Have or are suffering from other malignant tumors;
• Participating in other clinical trials;
• Pregnancy or lactation;
• Have uncontrolled cardiovascular disease;
• Severe complication, eg, uncontrolled hypertension;
• Mental disorder;
• Drug or alcohol addition;
• Do not have full capacity for civil acts.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-dose RT plus ICI	Intensity Modulated Radiation Therapy	Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Low-dose RT plus ICI	Chemotherapy	Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Low-dose RT plus ICI	Immune checkpoint inhibitor	Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
Low-dose RT plus ICI	Low-dose radiotherapy	Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.
IC+CCRT	Intensity Modulated Radiation Therapy	Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.
IC+CCRT	Chemotherapy	Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.

Primary Outcome Measures

Name	Time	Method
Progression free survival	3 years	From the date of randomization to local or regional recurrence, distant metastasis or any death

Secondary Outcome Measures

Name	Time	Method
Overall survival	3 years	From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Local recurrence-free survival	3 years	From the date of randomization to local recurrence or any death
Regional recurrence-free survival	3 years	From the date of randomization to regional recurrence or any death
Distant metastasis-free survival	3 years	From the date of randomization to distant metastasis or any death
Acute toxicities	From the start of treatment until 3 months post treatment	Assessed with CTCAE v5.0
Late toxicities	3 years post treatment	Assessed with RTOG/EORTC
Quality of life score	Through study completion, an average of 3 years	Assessed with EORTC-Quality of life questionnaire-C30 version 3.0

Trial Locations

Locations (3)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University; 🇨🇳 Nanning, Guangxi, China

Jiangxi Cancer Hospital; 🇨🇳 Nanchang, Jiangxi, China