Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma

NCT ID: NCT04004871

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2025-10-31

Brief Summary

Nasopharyngeal carcinoma (NPC) is commonly observed in southern China, particularly in the Pearl River delta area and the Xijiang River basin in the Guangdong and Guangxi provinces, with an incidence rate as high as 25-50 per 100,000. The National Comprehensive Cancer Network guidelines (version 1, 2018), have recommended use of induction chemotherapy followed by CCRT as category 2A for NPC, especially the TPF regimen as category 1 for EBV-associated disease. The nanoparticle albumin-bound paclitaxel (Nab-paclitaxel) is a promising new agent with more efficient entry to the tumor microenvironment and preferential uptake by cancer cells. Superior activity of Nab-paclitaxel regimens without the necessity for antianaphylactic pretreatments has been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of Nab-paclitaxel, cisplatin and Fluorouracil (APF) has not been determined in patients with locoregionally advanced NPC. In this prospective, Multi-centeric, Open, Non-controlled phase II clinical trial, investigators perform an exploratory study to the efficacy and Safety of APF.

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Cancer; Nasopharynx Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induction chemotherapy and concurrent chemoradiotherapy

Patients receive induction chemotherapy with Nab-paclitaxel, cisplatin and fluorouracil every three weeks for three cycles before radiotherapy, and then receive concurrent chemoradiotherapy.

Group Type: EXPERIMENTAL

Nab-paclitaxel, Cisplatin and Fluorouracil

Intervention Type: DRUG

Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.

concurrent chemoradiotherapy

Intervention Type: RADIATION

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Interventions

Nab-paclitaxel, Cisplatin and Fluorouracil

Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.

Intervention Type: DRUG

concurrent chemoradiotherapy

Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.

Intervention Type: RADIATION

Other Intervention Names

APF induction chemotherapy; Radical radiotherapy and concurrent cisplatin

Eligibility Criteria

Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).

2. Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).

3. No evidence of distant metastasis (M0).

4. EBV positive.

5. Satisfactory performance status: ECOG≤2.

6. Adequate marrow: leucocyte count ≥4000/uL, hemoglobin ≥90g/L and platelet count ≥100000/μL.

7. 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.

8. Adequate renal function: creatinine clearance ≥60 ml/min.

9. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria

1. WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.

2. Age>60 years or <18 years.

3. Treatment with palliative intent.

4. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.

5. Pregnancy or lactation.

6. History of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).

7. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes.

8. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liuzhou Workers' Hospital

OTHER_GOV

Sponsor Role: collaborator

Wuzhou Red Cross Hospital

OTHER

Sponsor Role: collaborator

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Kai Hu

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Countries

China

Other Identifiers

GuangxiMUHK1

Identifier Type: -

Identifier Source: org_study_id