Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma

NCT03851471 | Completed Early Phase 1

• 1 other identifier: JIUWEI-Gan 1-Ver1.0
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular carcinoma(HCC). The primary objective is to assess its therapeutic efficacy in patients with unresectable HCC. The primary endpoint is overall survival (OS) after the use of 12-week drug. Secondary endpoints include progression-free survival (PFS) after the use of 12-week drug, the improvement of the score of the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.

  Up to 12 weeks

Secondary Outcomes (8)

• Progression-Free Survival

  Baseline, 4 weeks, 8 weeks, 12 weeks

• European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)

  Baseline, 4 weeks, 8 weeks, 12 weeks

• The level of the liver function

  Baseline, 4 weeks, 8 weeks, 12 weeks

• The level of AFP

  Baseline, 4 weeks, 8 weeks, 12 weeks

• The level of coagulation function

  Baseline, 12 weeks

Study Arms (1)

Jiu-wei-zhen-xiao Granule

EXPERIMENTAL

Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.

Drug: Jiu-wei-zhen-xiao Granule

Interventions

Jiu-wei-zhen-xiao Granule DRUG

Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.

Jiu-wei-zhen-xiao Granule

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18\~75 years;
• Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
• (1) Histopathology; (2) Elevated serum alpha-fetoprotein (AFP) \>400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC; (3) Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).
• The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);
• \. Patients with hepatitis B virus infection;
• \. Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;
• \. Karnofsky score ≥60;
• \. Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

• Patients with unstable vital signs;
• Any uncontrolled, severe, intercurrent illness including but not limited to ongoing or active infection, heart, brain, lung and other systemic diseases or other kinds of tumors;
• Known history of allergy to the ingredients of this product;
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment;
• Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
• Patients who cannot take oral medication.

Sponsors & Collaborators

• Zhong Wang: lead

Study Sites (1)

Hubei Provincial Hospital of Traditional Chinese Medicine

Wuhan, Hubei, 430061, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-director

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: April 7, 2019
• Primary Completion: July 24, 2020
• Study Completion: March 30, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

CN (1)