Trials Sponsors Conditions Drugs Pricing

Conditions

Outcome Measures

Primary Outcomes (1)

Overall survival (OS)
OS is defined as the time from randomization to died from any cause. For the subjects who failed to visit, deletion is performed on the final date of knowing the survival of the subjects, for subjects who still survive, deletion is performed on the data expiration date.
2-4 years

Secondary Outcomes (6)

Progression-free survival (PFS)
2-3 years
Time to progress（TTP）
2-3 years
Overall response rate (ORR)
2-3 years
Overall disease control rate (DCR)
2-3 years
Assessment on Quality of life 1
2-4 years
+1 more secondary outcomes

Other Outcomes (2)

Biomarker analysis of proteome level (Immunohistochemical method)
2-4 years
Genome level (DNA, mRNA, miRNA) biomarker analysis
2-4 years

Study Arms (2)

Icaritin

EXPERIMENTAL

Icaritin:600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.

Drug: Icaritin

HUACHANSU PIAN

ACTIVE COMPARATOR

HUANCHANSU PIAN:Take orally 4 tablets/time(0.3g/tablet), 3 times/day(30 minutes after breakfast, lunch and dinner), continuous administration until reach the standard of termination.

Drug: HUACHANSU PIAN

Interventions

IcaritinDrug

Icaritin：600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.

Also known as: SNG-162

Icaritin

HUACHANSU PIANDrug

HUACHANSU PIAN:Take orally 4 tablets/time(0.3g/tablet), 3 times/day(30 minutes after breakfast, lunch and dinner), continuous administration until reach the standard of termination.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Only patients who meet all the following criteria are included in the study:
①Marrow: There is no blood transfusion and use of hematopoietic cell stimulating agent, including granulocyte colony stimulating factor (G-CSF)within 14 days before screening, platelet≥60×10E9/L, hemoglobin≥ 85g/L, white blood cell≥3.0×10E9/L; After a thorough measurement of the patient's condition, the above three items can be appropriately relaxed by the principal researchers at the research centre as: platelet 50 \~60×10E9/L, hemoglobin 80\~85g/L, white blood cell 2.5 \~3.0×10E9/L (contains critical values);

Sponsors & Collaborators

Yunnan Provinical Hospital of Traditional Chinese Medicine
Othercollaborator
Beijing Shenogen Biomedical Co., Ltd
Industrylead

Study Sites (28)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

Yueyin PanCONTACT

Yueyin PanPRINCIPAL INVESTIGATOR

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Kangsheng GuCONTACT

Kangsheng GuPRINCIPAL INVESTIGATOR

Cancer Hospital Chinese Academy of Medical Sciences

MeSH Terms

Interventions

icaritinSNG162

Study Officials

Yan Sun, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
PRINCIPAL INVESTIGATOR
Shukui Qin
NanJing PLA 81 Hospital
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Sun, MD

CONTACT

+86 10 67781331 suny@csco.org.cn

Shukui Qin

CONTACT

+86 25 80864806

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

August 2, 2017

Study Start

September 8, 2017

Actual (reported)

Primary Completion

You may not qualify if:

Patients who meet any of the following criteria are not allowed to enter the test:
Imaging examination shows that HCC liver tumors are huge (≥60% of the liver volume), or cancer embolus of portal trunk (occupying ≥50% of the vascular diameter), or cancer embolus invading mesenteric vein or inferior vena cava;
Middle or higher ascites which is clinically significant, it requires therapeutic abdominal paracentesis /drainage, or the Child-Pugh score \> 2;
Local anticancer therapy (including surgery, ablation, hepatic arterial chemotherapy, embolization or radiotherapy) or major surgery was performed 28 days prior to randomization;
Hepatocholangiocarcinoma and fibrolamellar cell carcinoma; In the past 5 years or at the same time, there were other malignancies, except cervical carcinoma in situ, previously treated basal cell carcinoma and superficial bladder tumor (Ta, Tis, T1);
Pregnant or lactating women;
The patient suffers from CTCAE classification type II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia; and/or NYHA standard III to IV cardiac dysfunction.
Allograft transplants including liver transplantation were performed previously, or a liver transplant was planned during the trial;
Hepatic encephalopathy and / or hepatic nephropathy occurred within 6 months;
Patient with active hepatitis C, that is, anti -HCV positive or HCV-RNA positive and abnormal liver function;
Human immunodeficiency virus (HIV) tests are positive or severe infection requiring systemic treatment with antibiotics;
Inability to swallow, chronic diarrhea or intestinal obstruction that significantly affecting medication intake and absorption;
Having a history of digestive tract bleeding within 6 months, or with a clear gastrointestinal bleeding tendency, including local active ulcerative lesions, positive fecal occult blood;
The patient has or is suspected to have known active autoimmune disease;
If a central nervous system metastasis is known and a metastasis of the central nervous system is suspected, the cranial MRI examination should be performed to exclude it;
+4 more criteria

The Phase III Study of Icaritin Versus HUACHANSU PIAN in Hepatocellular Carcinoma Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (2)

Study Arms (2)

Icaritin

HUACHANSU PIAN

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Other Outcomes (2)

Study Arms (2)

Icaritin

HUACHANSU PIAN

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (28)

MeSH Terms

Interventions

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations