Clinical trial NCT03356236: Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
Official title: A Multicenter, Prospective Cohort Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocarcinoma
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 828
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hepatocellular Carcinoma patients after Local Ablation

Brief summary: To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation

Detailed description: A multicenter, prospective cohort study investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation，to evaluate the efficacy and safety

Eligibility criteria: Inclusion Criteria:

1. 18 years ≤ Age ≤ 75 years, both male and female
2. Patients are diagnosed with HCC via examination of tissues according to Guidelines for Diagnosis and Treatment of Hepatocellular Carcinoma (Version 2017) by NHFPC (National Health and Family Planning Commission of the People's Republic of China) and/or HCC imaging criteria of American Association for the Study of Liver Diseases (AASLD) for the diagnosis of HCC;
3. Radiographic testing shows cancer cells have been eliminated after four weeks of Local Ablation;Complete Response (CR): Dynamic contrast-enhanced CT scans and follow-up MR images show low-density area of Hepatocellular Carcinoma and no enhancement during the arterial phase of contrast-enhanced CT; also patients with 0.5-1 cm beyond the limits of the tumor margins (considered as safe surgical margins) are eligible;
4. According to contrast-enhanced CT and MRI, with solitary tumor smaller than 5 cm in diameter; with multiple tumors (no more than 3 masses), the largest dimension is less than 3 cm;
5. Patients are eligible if Hemoglobin (Hb) count ≥90g/L, platelets count (PLT) ≥60×109/L, absolute neutrophil count (ANC) count \>1.0×109/L, prothrombin activity (PTA)\>50%, serum creatinine is less than 1.5 times ULN (Upper Limit of Normal) and total bilirubin (TBIL) \<51.3μmol/L (3 mg/dL);
6. ECOG score of 0-1;
7. Liver function is Child - Pugh grade A or B.
8. History of TACE for treatment of HCC is less than or equal to twice -
9. The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.

Exclusion Criteria:

1. Radiographic testing shows cancer cells have not been eliminated after four weeks of Local Ablation;
2. The occurrence of embolism occurs in large blood vessels on liver, patients with extrahepatic metastatic of HCC or liver transplantation;
3. Patients who are about to receive or already received chemotherapy or molecular targeted therapy;
4. Patients who are about to receive TACE treatment for HCC;
5. Patients without previous treatment of Huaier granules.
6. History of diabetes;
7. HCC patients with uncontrollable ascites at the beginning of enrollment of the study or are very likely to have ascites during the next four weeks at the time of enrollment; patients with hepatic encephalopathy or upper gastrointestinal bleeding;
8. Patients have basic diseases including severe cardiopulmonary insufficiency, renal insufficiency, or severe mental illness;
9. Patients with other infectious disease (excluding viral hepatitis)
10. Patients who cannot take oral medication;
11. Conditions that are considered not suitable for this study investigators.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 96 weeks
Secondary outcomes:
measure: Recurrence-Free Survival (RFS)
timeFrame: 96 weeks
measure: Time to recurrence (TTR)
timeFrame: Time from baseline to relapse (up to 96 weeks)
measure: Overall Survival (OS)
timeFrame: Time from baseline to death (up to 96 weeks)
measure: Change From Baseline in Quality of Life (QOL)
timeFrame: 24, 48, 72, 96 weeks
measure: Incidence rate of Adverse events (AE)
timeFrame: 96 weeks
measure: severity of Adverse events (AE)
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: Shijiazhuang Fifth Hospital
state: Hebei
city: Harbin
country: China
facility: Affiliated Cancer Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Dalian
country: China
facility: The Affiliated Zhongshan Hospital of Dalian University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Hangzhou
country: China
facility: the Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Beijing You 'an Hospital, Capital Medical University
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Yue Han, Professor
role: PRINCIPAL_INVESTIGATOR
References: