Using Huaier Granule to prevent liver cancer recurrence after treatment

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

This study is testing if Huaier Granule can help prevent liver cancer from coming back in patients who have already had their cancer treated.

Quick facts

• Study type: Observational
• Enrollment: 828 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Guangzhou, Guangdong and 16 other locations)
• Trial ID: NCT03356236 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective cohort study aims to evaluate the efficacy and safety of Huaier Granule in preventing the recurrence and metastasis of hepatocarcinoma following local ablation. Patients diagnosed with hepatocellular carcinoma (HCC) will be monitored after their cancer cells have been eliminated through local ablation. The study will assess how well Huaier Granule can help maintain a complete response and prevent further cancer development. The research will involve multiple hospitals to gather a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have been diagnosed with hepatocellular carcinoma and have shown a complete response to local ablation.

Not a fit: Patients with advanced liver cancer or those who have not achieved a complete response after local ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the risk of liver cancer recurrence for patients after local ablation.

How similar studies have performed: While there is limited data on the specific use of Huaier Granule, similar approaches in cancer recurrence prevention have shown promise in other studies.

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.

Where this trial is running

Guangzhou, Guangdong and 16 other locations

• 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, 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)

Study contacts

• Principal investigator: Yue Han, Professor — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Yue Han, Professor

Conditions: Hepatocarcinoma