IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

Last updated: May 13, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

3

Condition

Carcinoma

Cancer

Chemotherapy

Treatment

Low-dose radiotherapy

Intensity Modulated Radiation Therapy

Chemotherapy

Clinical Study ID

NCT05941741
Low-dose RT in NPC
  • Ages 18-70
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHOII/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 (includingimmunotherapy);

  • No contraindications to chemotherapy, radiotherapy or immunotherapy;

  • Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocytecount ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanineaminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; bloodurea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinineclearance ≥ 60ml/min (Cockcroft-Gault formula);

  • Sign the consent form.

Exclusion

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

Total Participants: 380
Treatment Group(s): 4
Primary Treatment: Low-dose radiotherapy
Phase: 3
Study Start date:
January 10, 2024
Estimated Completion Date:
December 31, 2029

Connect with a study center

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Site Not Available

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi
    China

    Site Not Available

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