Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
NCT ID: NCT03356236
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
828 participants
OBSERVATIONAL
2018-04-17
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer
NCT05660213
HAIC Combined with Donafenib and Sintilimab As Perioperative Treatment for Resectable Hepatocellular Carcinoma Patients At High Risk of Recurrence
NCT06812039
Adjuvant Treatment of Patients With High Risk of Recurrent Hepatocellular Carcinoma With Donafenib in Combination With Envafolimab
NCT06498622
A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer
NCT04784520
Effect of Huaier Granule on Nephrotoxicity Associated With Targeted Therapy for Advanced Hepatobiliary Malignancies.
NCT05673824
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yue Han
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yue Han
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yue Han, Professor
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 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
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 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
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Han
Role: CONTACT
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jiaping Li
Role: primary
Chidan Wan
Role: primary
Zixiang Li
Role: primary
Bo Zhai
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HE-201708
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.