HepatocarcinomaNCT03356236
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
An observational study of Hepatocarcinoma, run by Yue Han at 17 sites in China.
Trial summary
To evaluate the efficacy and safety of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocarcinoma
- How many people
- 828 participants
- Where
- 17 sitesChina
- Study dates
- 17 Apr 2018to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular Carcinoma patients after Local Ablation
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
17 sites in 1 country.
Han contact
17 sites in 1 country
China17 sites, 16 recruiting
- Recruiting
Beijing You 'an Hospital, Capital Medical University
Beijing
Jiasheng Zheng, +86-13901355160, 13901355160@163.com
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
Yue Han, +86-13511021629, doctorhan@163.com
- Suspended
Chinese PLA General Hospital
Beijing
- Recruiting
Chongqing Cancer Hospital
Chongqing
Qingdong Li, +86-13650582046, xj2010045@163.com
- Recruiting
The Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning
Jun Zhou, +86-18698629436, zhoujun7092@163.com
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
Lei Song, +86-17709876600, songlei_1975@126.com
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Jiaping Li, +86-13352890908
- Recruiting
the Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhe Tang, professor, +86-13757118212, dicktang@sina.com
- Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang
Ruibao Liu, +86-13936586155, ruibaoliu@hotmail.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Xin Ye, +86-15168887755, yexintaian@aliyun.com
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong
Yuliang Li, +86-13573780666, lyl.pro@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Zixiang Li, +86-18669739263
- Recruiting
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
Bo Zhai, +86-13918656019
- Recruiting
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei
Huanwei Zheng, +86-13323119317, 13323119317@163.com
- Recruiting
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Chidan Wan, +86-13871289836
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Jun Xu, +86-13700222215, xujun1964@xjtufh.edu.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Hailaing Li, +86-13903861969, cjr.lihailiang@vip.163.com
About this study
Official title: 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 of Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma following Local Ablation
Read the 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
- Conditions
- Hepatocarcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined as the duration of time from start of treatment to time of disease progression.
Measured: 96 weeks
Secondary outcomes (6)
Recurrence-Free Survival (RFS)
RFS was defined as the duration of time from start of treatment to time of disease recurrence .
Measured: 96 weeks
Time to recurrence (TTR)
TTR was defined as the time from shart of treatment to disease recurrence.
Measured: Time from baseline to relapse (up to 96 weeks)
Overall Survival (OS)
OS was defined as the time from start to death from any cause or last patient last visit.
Measured: Time from baseline to death (up to 96 weeks)
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.
Measured: 24, 48, 72, 96 weeks
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.
Measured: 96 weeks
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.
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start17 Apr 2018
- Primary completion26 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 828 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yue Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yue Han, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yue Han, Professor, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356236
- Sponsor's protocol ID
- HE-201708
- Status last verified
- May 2024
- First submitted
- 12 Nov 2017
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective Cohort Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma Following Local Ablation
- ClinicalTrials.gov ID
- NCT03356236
- Acronym / sponsor ID
- HE-201708
- Conditions
- Hepatocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 828 participants (estimated)
- Lead sponsor
- Yue HanUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 26 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular Carcinoma patients after Local Ablation
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: 96 weeks
Time to recurrence (TTR)
Time frame: Time from baseline to relapse (up to 96 weeks)
Overall Survival (OS)
Time frame: Time from baseline to death (up to 96 weeks)
Change From Baseline in Quality of Life (QOL)
Time frame: 24, 48, 72, 96 weeks
Incidence rate of Adverse events (AE)
Time frame: 96 weeks
severity of Adverse events (AE)
Time frame: 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han contact
Yue Han, Professor principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocarcinoma, run by Yue Han at 17 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Han, Professor (+0086-13511021629, doctorhan001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.