IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 3

Conditions: Chemotherapy; Immune Checkpoint Inhibitor; Nasopharyngeal Carcinoma; Radiotherapy

Treatments: Biological: Immune checkpoint inhibitor; Drug: Chemotherapy; Radiation: Intensity Modulated Radiation Therapy; Radiation: Low-dose radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05941741

Low-dose RT in NPC

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Low-dose RT plus ICI

Experimental group

Description:

Patients will receive induction chemotherapy plus low-dose radiotherapy and immuce checkpoint inhibitor then followed by concurrent chemoradiotehrapy.

Treatment:

Radiation: Low-dose radiotherapy

Radiation: Intensity Modulated Radiation Therapy

Drug: Chemotherapy

Biological: Immune checkpoint inhibitor

IC+CCRT

Active Comparator group

Description:

Patients will receive induction chemotherapy plus concurrent chemoradiotehrapy.

Treatment:

Radiation: Intensity Modulated Radiation Therapy

Drug: Chemotherapy