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Clinical Trials/NCT03356236
NCT03356236RecruitingNot Applicable

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

Yue Han17 sites in 1 country828 target enrollmentStarted: April 17, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
828
Locations
17
Primary Endpoint
Progression-free survival (PFS)

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 18 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Progression-free survival (PFS)

Time Frame: 96 weeks

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

Secondary Outcomes

  • Recurrence-Free Survival (RFS)(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)
  • Time to recurrence (TTR)(Time from baseline to relapse (up to 96 weeks))
  • severity of Adverse events (AE)(96 weeks)
  • Incidence rate of Adverse events (AE)(96 weeks)

Investigators

Sponsor
Yue Han
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Yue Han

Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Sites (17)

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