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

NCT06095167 | Not Yet Recruiting Phase 3

• 1 other identifier: NPC010
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Failure-free survival

  Failure-free survival rate is calculated from the date of randomization to the date of treatment failure or death from any cause, whichever is first

  3 years

Secondary Outcomes (3)

• Overall survival

  3 years

• Locoregional failure-free survival

  3 years

• Distant failure-free survival

  3 years

Study Arms (2)

The immunotherapy and induction chemotherapy plus RT alone group

EXPERIMENTAL

Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for three cycles before radiotherapy, and then receive intensity modulated-radiotherapy (IMRT) alone.

Drug: without concurrent cisplatin chemotherapy

The immunotherapy and induction chemotherapy plus CCRT group

ACTIVE COMPARATOR

Patients receive Anti-PD-1 Antibody, gemcitabine (1000 mg/m² d1,8) , cisplatin (80mg/m² d1) every 3 weeks for three cycles and cisplatin 80-100 mg/m² every 3 weeks for 2 cycles, concurrently with intensity-modulated radiotherapy (IMRT)

Drug: with concurrent cisplatin chemotherapy

Interventions

without concurrent cisplatin chemotherapy DRUG

IMRT without concurrent cisplatin chemotherapy

The immunotherapy and induction chemotherapy plus RT alone group

with concurrent cisplatin chemotherapy DRUG

IMRT with concurrent cisplatin chemotherapy

The immunotherapy and induction chemotherapy plus CCRT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

Study Sites (1)

Department of radiation oncology, Fujian cancer hospital

Fuzhou, Fujian, 350014, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Shaojun Lin, MD

CONTACT

13860603879; linshaojun@yeah.net

Qiaojuan Guo, MD

CONTACT

15080013157; guoqiaojuan@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)