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

Zhong Wang

Status and phase: Completed; Early Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Jiu-wei-zhen-xiao Granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03851471

JIUWEI-Gan 1-Ver1.0

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age:18~75 years;
2. 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).

3.The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);

4. Patients with hepatitis B virus infection;

5. Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;

6. Karnofsky score ≥60;

7. Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

1. Patients with unstable vital signs;
2. 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;
3. Known history of allergy to the ingredients of this product;
4. 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;
5. Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
6. Patients who cannot take oral medication.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Jiu-wei-zhen-xiao Granule

Experimental group

Description:

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.

Treatment:

Drug: Jiu-wei-zhen-xiao Granule