MedTrace Logo

Effect of Babaodan on Tumor Recurrence After Curative Resection of Hepatocellular Carcinoma

NCT03515369 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2018-05-03

No results posted yet for this study

Summary

The aim of this study is to evaluate the effect of traditional Chinese medicine Babaodan on tumor recurrence of hepatocellular carcinoma after curative resection, as well as the safety of this treatment

Conditions

Interventions

DRUG

Babaodan oral capsule

On the basis of conventional liver protecting treatment, take Babaodan oral capsule within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.

DRUG

Placebo oral capsule

On the basis of conventional liver protecting treatment, take Placebo oral capsule began within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Meng Chao Hepatobiliary Hospital of Fujian Medical University

    collaborator OTHER

  • Sun Yat-sen University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    collaborator OTHER

  • Second Military Medical University

    collaborator OTHER

  • Xiamen Traditional Chinese Medicine Co., Ltd.

    collaborator UNKNOWN

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Feng Shen, MD, PhD · Eastern Hepatobiliary Surgery Hospital, Shanghai, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2022-01-31
Completion
2022-06-30

More Related Trials

Entities

Diseases

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 NCT03515369 on ClinicalTrials.gov