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A Safety and Efficacy Trial of Docetaxel With or Without XH1 in Non-small Cell Lung Cancer (NSCLC) Patients

NCT03407300 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-09-13

No results posted yet for this study

Summary

This is a prospective, randomized, multicenter clinical study designed to evaluate its safety and efficacy by using Docetaxel with or without Traditional Chinese Medicine XH1 in patients with Stage ⅢB-Ⅳ Non-small Cell Lung Cancer (NSCLC) who failed with first-line Chemotherapy. The primary outcome measure includes progression-free survival (PFS) after treatment. Secondary outcome measures include collecting biomarkers before and during treatment, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and patient's quality of life.

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Docetaxel

To evaluate the safety and efficacy of Docetaxel alone in stage III-IV NSCLC patients

DRUG

Chinese traditional medicine XH1

To evaluate the safety and efficacy of Docetaxel combined with Chinese tradition medicine XH1 in stage III-IV NSCLC patients

Sponsors & Collaborators

  • Alphacait, LLC

    collaborator OTHER

  • Haining Health-Coming Biotech Co., Ltd.

    lead OTHER

Principal Investigators

  • Enguo Chen, MD · Sir Run Run Shaw Hospital

  • Haizhou Lou, MD · Sir Run Run Shaw Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-02-01
Completion
2019-02-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT03407300 on ClinicalTrials.gov