Clinical trial NCT03851471: Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
Official title: An Open-label, Single-institution, Non-randomized, Single-arm, Pilot Study of Jiu-wei-zhen-xiao Granule for the Treatment in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Progression-Free Survival
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: The level of the liver function
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: The level of AFP
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: The level of coagulation function
timeFrame: Baseline, 12 weeks
measure: The size of solid tumors
timeFrame: Baseline, 12 weeks
measure: "Du-tan-yu-jie Zheng" symptoms score in Chinese medicine
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: 10cm-VAS of the pain
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Provincial Hospital of Traditional Chinese Medicine
state: Hubei
Study officials:
References: