Status:
COMPLETED
Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
Lead Sponsor:
Zhong Wang
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
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). T...
Eligibility Criteria
Inclusion
- 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);
- 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
- 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.
Key Trial Info
Start Date :
April 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03851471
Start Date
April 7 2019
End Date
March 30 2021
Last Update
April 9 2021
Active Locations (1)
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1
Hubei Provincial Hospital of Traditional Chinese Medicine
Wuhan, Hubei, China, 430061