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IC Plus Low-dose Radiation Plus Cadonilimab in LANPC

RecruitingPhase 3Ages 18 Years - 70 YearsAllSun Yat-sen University
NCT05941741 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Intensity Modulated Radiation Therapy
  • Chemotherapy
  • Immune checkpoint inhibitor
  • Low-dose radiotherapy
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Where

3 sites
Cancer Center, Sun Yat-sen University
Guangzhou, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, China
Jiangxi Cancer Hospital
Nanchang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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