Health Trials

About this trial

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

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

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

Treatment groups

380 Participants
are divided into 2 treatment groups

Locations

3
Cancer Center, Sun Yat-sen University GuangzhouGuangdong, China
The First Affiliated Hospital of Guangxi Medical University NanningGuangxi, China
Jiangxi Cancer Hospital NanchangJiangxi, China

Sponsors and collaborators

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov