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

NCT03236636 | Unknown Phase 3 DMC

• 1 other identifier: SNG1705ICR-1
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 28

Brief Summary

The enriched HBV-related advanced HCC patient population (composite biomarker score ≥ 2) and overall survival (OS) were compared between the two groups.

Conditions

Advanced HBV-Related Hepatocellular Carcinoma (HCC)

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

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

Icaritin DRUG

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 PIAN DRUG

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.

Also known as: HUACHANSU PIAN（999）

HUACHANSU PIAN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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);
• ②Liver: Total bilirubin≤1.5 times of the upper limit of normal(ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤5 × ULN; albumin≥ 28g/L;
• ④ Kidney: Serum creatinine≤ 1.5 x ULN, or creatinine clearance rate≥ 50ml/min; 13) If HBV-DNA≥104 copies/ml(2000IU/ml), antiviral therapy must be done first, the patient can be included in the group until HBV-DNA\<104 copies /ml(2000IU/ml); and continue to take antiviral drugs, monitor liver function and hepatitis B virus load; 14) Women of childbearing age must receive pregnancy tests 14 days before treatment and the results are negative; Men of childbearing age need effective contraception during treatment and within 3 months after treatment; 15) Patients are volunteered to join the study, sign the informed consent, have good compliance and cooperate with follow-up; 16) The subjects do not participate in other clinical trials within 4 weeks before screening; If the subject fails in other test screening, but meets the requirements of this test, then can be enrolled.

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;

Sponsors & Collaborators

• Beijing Shenogen Biomedical Co., Ltd: lead
• Chinese Academy of Medical Sciences: collaborator
• NanJing PLA 81 Hospital: collaborator
• Peking University Cancer Hospital & Institute: collaborator
• Beijing Hospital: collaborator
• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: collaborator
• Jinan Central Hospital: collaborator
• Linyi Tumour Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Anhui Provincial Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• First People's Hospital of Foshan: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• The First Hospital of Jilin University: collaborator
• Haikou People's Hospital: collaborator
• Fudan University: collaborator
• West China Hospital: collaborator
• Chongqing Traditional Chinese Medicine Hospital: collaborator
• Chifeng Municipal Hospital: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Guilin Medical University, China: collaborator
• The Third Xiangya Hospital of Central South University: collaborator
• Yunnan Provincial Hospital of Traditional Chinese Medicine: collaborator
• The Sixth People's Hospital of Shenyang: collaborator

Study Sites (28)

Anhui Provincial Hospital

Hefei, Anhui, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

General Hospital of Chinese Armed Police Forces

Beijing, Beijing Municipality, China

TERMINATED

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

Chongqing Traditional Chinese Medicine Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, China

RECRUITING

Affiliated Hospital of Guilin Medical University

Guilin, Guangxi, China

RECRUITING

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, China

RECRUITING

Haikou People's Hospital

Haikou, Hainan, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Eastern Theater General Hospital,QinHuai District Medical Area

Nanjing, Jiangsu, 210002, China

RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Tumor Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

The Sixth People's Hospital in Shenyang

Shenyang, Liaoning, China

RECRUITING

Chifeng Municipal Hospital

Chifeng, Neimenggu, China

RECRUITING

Jinan Central Hospital

Jinan, Shandong, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China

RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, China

RECRUITING

MeSH Terms

Interventions

icaritin; SNG162

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; qinsk@csco.org.cn

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

Model Details: multicenter, randomized, double-blind, double-dummy, adaptive enrichment design

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: August 2, 2017
• Study Start: September 8, 2017
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)