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Albumin-bound Paclitaxel Combined With Cisplatin Versus Docetaxel Combined With Cisplatin Induced Chemotherapy in Advanced Head and Neck Squamous Tummor

NCT04766827 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2021-02-23

No results posted yet for this study

Summary

Research Topic:

A prospective randomized controlled clinical study of albumin-bound paclitaxel combined with cisplatin (AP regimen) versus docetaxel combined with cisplatin (TP regimen) induced chemotherapy in advanced head and neck squamous cell carcinoma

Expected study duration:

Each subject received a 3-week regimen of AP or TP over 2 cycles.

Research objectives:

To evaluate the efficacy and safety of induction chemotherapy with albumin-bound paclitaxel in patients with advanced head and neck squamous cell carcinoma (HSCC), two induction chemotherapy regimens, AP regimen and TP regimen, were compared.

Trial Design. Single center, open label, controlled clinical study Number of cases: 116 Objective response rate (ORR=CR+PR) was used as the main evaluation index in this study.

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DRUG

albumin-bound paclitaxel

Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Xudong Wang, MD · Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center of Cancer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-12
Primary Completion
2021-11-30
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04766827 on ClinicalTrials.gov