The Phase II Study of Icaritin in Patients With Advanced Hepatocellular Carcinoma

NCT01972672 | Completed Phase 2

• 1 other identifier: QU1305ICR
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of the study is to assess the time to progression (TTP) in patients with advanced HCC treated with Icaritin .

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• time to progress（TTP）

  The study will be an open-label, single-armed study to evaluate the clinical benefit of Icaritin 600 mg twice daily with oral administration for total of 1200 mg daily added to Best Supportive Care in patients with advanced HCC.

  1-2 years

Secondary Outcomes (7)

• Progression-free survival (PFS)

  1-2 years

• Overall survival (OS)

  1-2 years

• Overall response rate (ORR) (proportion of patients with confirmed partial and complete responses)

  1-2 years

• Overall disease control rate (DCR)

  1-2 years

• Assessment on Quality of life

  1-2 years

Other Outcomes (3)

• p-STAT3 and ER-α36 expression

  1-2 years

• Blood biomarkers of estradiol (E2), hepatocyte growth factor (HGF), interleukin-6 (IL-6), transforming growth factor β (TGF-β), and alpha-fetoprotein (AFP);

  1-2 years

• Gene expression profiling of blood cells and tumor biopsies

  1-2 years

Study Arms (1)

Icaritin

EXPERIMENTAL

Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg

Drug: Icaritin

Interventions

Icaritin DRUG

Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg

Also known as: SNG-162

Icaritin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be entered in the study only if they meet all of the following criteria:
• The age is between 18 and 75.
• Patients who have HCC which should be histologically or cytologically confirmed. At least one lesion, not previously treated ( can be accurately measured at baseline as ≥ 10 mm in the longest diameter with computed tomography (CT) per RECIST 1.1)
• Patients who cannot accept or is not willing to have surgery or any interventional therapy via hepatic artery, or had surgery and any Interventional therapy via hepatic artery more than 4 weeks with disease progression, and cannot tolerate Sorafenib or Oxaliplatin doublet chemotherapy or cannot use or refused to use them
• Child-Pugh status A or B (≤7) ( Either albumin or haemachrome is \>2)
• ECOG PS: 0 or 1.
• Patients who have a life expectancy of at least 12 weeks.
• Patients who have not received chemotherapy and target therapy. If patients received radiation therapy or surgery, the treatment should be at least 4 weeks prior to enrollment and any AE and wounds during the treatment should be recovered. If patient received adjuvant chemotherapy, the treatment should be at least 6 months prior to enrollment.
• Meet following laboratory parameters:
• Haematology ( no blood transfusion or Blood products or Hematopoietic growth factor within 14 days)
• Hemoglobin ≥ 90 g/dL
• Neutrophil cell count≥1.5 × 10\^9/L
• Platelet count ≥ 80 × 10\^9/L
• Clinical chemistry,
• Albumin ≥ 29 g/dL (no albumin transfusion or blood product within 14 days)

You may not qualify if:

• Patients who meet with any below criterion should not be included in the study:
• Previously known intrahepatic cholangiocarcinoma, mixed cell carcinoma and fibrolamellar carcinoma; previous or concurrent malignant tumor (healed skin basal cell carcinoma and carcinoma in situ of uterine cervix are not included);
• Women in pregnancy or lactation;
• Patients who have hypertension and blood pressure are not well controlled after treatments with antihypertensive drugs (systolic pressure \> 150mmHg, diastolic pressure \>100mmHg); patients who have grade II or higher myocardial ischemia or myocardial infarction and poorly controlled arrhythmia (including QTC interval≥ 450ms) and grade III-IV cardiac insufficiency according to NYHA criteria; Ultrasound Cardiogram on heart: LVEF (left ventricular ejection fraction)\<50%;
• Patients are incapable of swallow, or have chronic diarrhea or intestinal obstruction, which significantly affects administration and absorption of study drug;
• Patients potentially have gastrointestinal hemorrhage (such as local active ulcer foci, occult blood in stools ++ or even higher), previous medical records of alimentary tract hemorrhage within six months;
• Patients who have central nervous system metastasis;
• Patients who have coagulation disorder (prothrombin time \> 16s, activated partial thromboplastin time \> 43s, thrombin time \>21s, fibrinogen\< 2g/L), subjects showing hemorrhagic tendency or accepting thrombolytic or anticoagulant therapy;
• Patients who have psychiatric disorders or previous medical history of psychotropic drug abuse;
• Patients who have seroperitoneum with clinical symptoms, requring remedial abdominal paracentesis or drainage, or Child-Pugh score ≥2.

Sponsors & Collaborators

• Beijing Shenogen Biomedical Co., Ltd: lead
• Chinese Academy of Medical Sciences: collaborator
• NanJing PLA 81 Hospital: collaborator
• 307 Hospital of PLA: collaborator
• Qingdao University: collaborator

Study Sites (3)

Cancer institute & hospital, chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Shenogen Biomedical Co., Ltd

Beijing, Beijing Municipality, 102206, China

Location

NanJing PLA 81 Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

icaritin; SNG162

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yan Sun, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• ShuKui Qin, MD

  NanJing PLA 81 Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 30, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: March 1, 2017
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

CN (3)