Induction chemotherapy with low-dose radiation and cadonilimab for locally advanced nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, randomized phase III trial comparing induction chemotherapy combined with low-dose radiation and cadonilimab followed by concurrent chemoradiotherapy versus induction chemotherapy followed by standard concurrent chemoradiotherapy. Eligible patients are adults 18–70 years with newly diagnosed non-keratinizing loco-regionally advanced nasopharyngeal carcinoma (T4N1M0 or T1-4N2-3M0) and ECOG 0–1. Interventions include intensity-modulated radiation therapy, standard chemotherapy, low-dose radiotherapy during induction, and the immune checkpoint inhibitor cadonilimab, with participants randomized to the experimental or control arm. Primary outcomes compare treatment efficacy, treatment-related adverse events, and patient-reported quality of life between the two groups with planned follow-up for survival and toxicity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Center, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Not yet recruiting
• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Not yet recruiting

Study contacts

• Principal investigator: Chong Zhao, MD, PhD — Sun Yat-Sen University Cancer Center
• Study coordinator: Chong Zhao, MD, PhD
• Email: zhaochong@sysucc.org.cn
• Phone: 02087342638

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.