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

NCT03356236 | Recruiting DMC

• 1 other identifier: HE-201708
• Study Type: observational
• Target: 828
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Hepatocarcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  PFS was defined as the duration of time from start of treatment to time of disease progression.

  96 weeks

Secondary Outcomes (6)

• Recurrence-Free Survival (RFS)

  96 weeks

• Time to recurrence (TTR)

  Time from baseline to relapse (up to 96 weeks)

• Overall Survival (OS)

  Time from baseline to death (up to 96 weeks)

• Change From Baseline in Quality of Life (QOL)

  24, 48, 72, 96 weeks

• Incidence rate of Adverse events (AE)

  96 weeks

Study Arms (2)

Observation group 1

All treatments of patients after Local Ablation are prescribed by a physician on the basis of usual clinical practice.Patients who maybe receive Huaier Granule are as observation group 1

Observation group 2

All treatments of patients after Local Ablation are prescribed by a physician on the basis of usual clinical practice.Patients who maybe not receive Huaier Granule are as observation group 2

Eligibility Criteria

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

Study Population

Hepatocellular Carcinoma patients after Local Ablation

You may qualify if:

• years ≤ Age ≤ 75 years, both male and female
• 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;
• 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;
• 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;
• 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);
• ECOG score of 0-1;
• Liver function is Child - Pugh grade A or B.
• History of TACE for treatment of HCC is less than or equal to twice -
• The patients are volunteered for the study, sign informed consent form and cooperate with Investigator to collect data.

You may not qualify if:

• Radiographic testing shows cancer cells have not been eliminated after four weeks of Local Ablation;
• The occurrence of embolism occurs in large blood vessels on liver, patients with extrahepatic metastatic of HCC or liver transplantation;
• Patients who are about to receive or already received chemotherapy or molecular targeted therapy;
• Patients who are about to receive TACE treatment for HCC;
• Patients without previous treatment of Huaier granules.
• History of diabetes;
• 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;
• Patients have basic diseases including severe cardiopulmonary insufficiency, renal insufficiency, or severe mental illness;
• Patients with other infectious disease (excluding viral hepatitis)
• Patients who cannot take oral medication;
• Conditions that are considered not suitable for this study investigators.

Sponsors & Collaborators

• Yue Han: lead

Study Sites (17)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Shijiazhuang Fifth Hospital

Shijiazhuang, Hebei, China

RECRUITING

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

The Second Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

the Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Beijing You 'an Hospital, Capital Medical University

Beijing, China

RECRUITING

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Chinese PLA General Hospital

Beijing, China

SUSPENDED

Chongqing Cancer Hospital

Chongqing, China

RECRUITING

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

• Yue Han, Professor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yue Han, Professor

CONTACT

+0086-13511021629; doctorhan001@163.com

Han

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 29, 2017
• Study Start: April 17, 2018
• Primary Completion: August 26, 2024
• Study Completion: December 31, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)