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Jiu-wei-zhen-xiao Granule

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |China Pharma Holdings, Inc.|Last Updated: Apr 9, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03851471Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular CarcinomaEARLY_PHASE1 COMPLETED 10Apr 7, 2019Mar 30, 2021Apr 9, 20211 China
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Study Endpoints
Primary Endpoints
Overall Survival
Up to 12 weeks

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

Secondary Endpoints
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
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Jiu-wei-zhen-xiao GranuleEXPERIMENTALPatients 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.
Interventions
NameTypeDescription
Jiu-wei-zhen-xiao GranuleDRUGPatients 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.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ch...

Countries:China
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