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

NCT04004871 | Completed Phase 2 DMC

• 1 other identifier: GuangxiMUHK1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  To be determined by measurement of target lesions according to RECIST criteria

  3 years

Secondary Outcomes (3)

• Failure-free survival (FFS)

  3 years

• Overall survival（OS）

  3 years

• Adverse Events

  3 years

Study Arms (1)

Induction chemotherapy and concurrent chemoradiotherapy

EXPERIMENTAL

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

Drug: Nab-paclitaxel, Cisplatin and Fluorouracil; Radiation: concurrent chemoradiotherapy

Interventions

Nab-paclitaxel, Cisplatin and Fluorouracil 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.

Also known as: APF induction chemotherapy

Induction chemotherapy and concurrent chemoradiotherapy

concurrent chemoradiotherapy RADIATION

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

Also known as: Radical radiotherapy and concurrent cisplatin

Induction chemotherapy and concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with newly histologically confirmed non-keratinizing (according to World Health Organization (WHO) histologically type).
• Tumor staged as T3-4/N1-3 (according to the 8th UICC edition).
• No evidence of distant metastasis (M0).
• EBV positive.
• Satisfactory performance status: ECOG≤2.
• Adequate marrow: leucocyte count ≥4000/uL, 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\>60 years or \<18 years.
• Treatment with palliative intent.
• Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
• Pregnancy or lactation.
• History of previous radiotherapy (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

• Guangxi Medical University: lead
• Liuzhou Workers' Hospital: collaborator
• Wuzhou Red Cross Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Fluorouracil; Chemoradiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: March 28, 2019
• Primary Completion: March 29, 2022
• Study Completion: October 31, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

CN (1)