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Clinical Trials in China / NCT06095167
Starting soon Phase 3

Induction Chemotherapy and Immunotherapy Combined Radiotherapy With or Without Concurrent Chemotherapy for Stage III-IVa NPC

NCT06095167 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Cancer Hospital
Phase
Phase 3
Started
2024-01-01
Last updated
2023-10-23

Condition(s) studied

Nasopharyngeal Carcinoma

Investigational drug(s) / intervention(s)

without concurrent cisplatin chemotherapywith concurrent cisplatin chemotherapy

without concurrent cisplatin chemotherapy: IMRT without concurrent cisplatin chemotherapy

with concurrent cisplatin chemotherapy: IMRT with concurrent cisplatin chemotherapy

Study summary

The purpose of this study is to compare induction chemotherapy (gemcitabine+cisplatin) plus immunotherapy with concurrent chemoradiotherapy (CCRT) or RT alone in patients with stage III-IVa nasopharyngeal carcinoma(NPC), in order to confirm the value of Immunotherapy and concurrent chemotherapy in NPC patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with newly histologically confirmed non-keratinizing (according to WHO histologically type). * Tumor staged as III-Iva(except T3N0M0) (according to the 8th AJCC edition). * No evidence of distant metastasis (M0). * Satisfactory performance status: Karnofsky scale (KPS) ≥ 70. * Adequate marrow: leucocyte count ≥ 4000/μL, hemoglobin ≥ 90g/L and platelet count ≥ 100000/μL. * Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) \< 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ ULN. * Adequate renal function: creatinine clearance ≥ 60 ml/min. * Patients must be informed of the investigational nature of this study and give written informed consent. Exclusion Criteria: * WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma. * Age \> 65 or \< 18. * Treatment with palliative intent. * Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. * Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). * History of previous RT (except for non-melanomatous skin cancers outside intended RT treatment volume). * Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes. * Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \> 1.5×ULN), and emotional disturbance.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of radiation oncology, Fujian cancer hospital Fuzhou Fujian

More Fujian Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06095167 on ClinicalTrials.gov ↗ ← All trials in China