Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation

Hepatocarcinoma Clinical Trial

Official title:

A Multicenter, Prospective Cohort Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03356236
• Other study ID #: HE-201708
• Status: Recruiting
• Start date: April 17, 2018
• Est. completion date: August 26, 2024

Study information

• Verified date: December 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Yue Han, Professor
• Phone: +0086-13511021629
• Email: doctorhan001[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 828
• Est. completion date: August 26, 2024
• Est. primary completion date: August 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocarcinoma
• Recurrence

Locations

Country	Name	City	State
China	Beijing You 'an Hospital, Capital Medical University	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing
China	Chinese PLA General Hospital	Beijing
China	Chongqing Cancer Hospital	Chongqing
China	The Affiliated Zhongshan Hospital of Dalian University	Dalian	Liaoning
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	the Second Affiliated Hospital Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shandong Provincial Hospital	Jinan	Shandong
China	The Second Hospital of Shandong University	Jinan	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai
China	Shijiazhuang Fifth Hospital	Shijiazhuang	Hebei
China	Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Yue Han

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	PFS was defined as the duration of time from start of treatment to time of disease progression.	96 weeks
Secondary	Recurrence-Free Survival (RFS)	RFS was defined as the duration of time from start of treatment to time of disease recurrence .	96 weeks
Secondary	Time to recurrence (TTR)	TTR was defined as the time from shart of treatment to disease recurrence.	Time from baseline to relapse (up to 96 weeks)
Secondary	Overall Survival (OS)	OS was defined as the time from start to death from any cause or last patient last visit.	Time from baseline to death (up to 96 weeks)
Secondary	Change From Baseline in Quality of Life (QOL)	Quality of Life (QOL) were measured using supplemental quality of life questions. Item score range(12 items): 1 (worst symptom) to 5 (no symptom). Change: score at 96 weeks minus score at baseline.	24, 48, 72, 96 weeks
Secondary	Incidence rate of Adverse events (AE)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	96 weeks
Secondary	severity of Adverse events (AE)	An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	96 weeks