Hepatic CarcinomaPhase 4NCT01770431
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
A Phase 4 study testing Huaier Granule in people with Hepatic Carcinoma, run by Qidong Gaitianli Medicines Co., Ltd at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Carcinoma
- What is being tested?
- Huaier Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,044 participants
- Where
- 1 siteChina
- Study dates
- Aug 2011to Aug 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age: ≥ 18 and ≤ 75 years, both male and female;
- Radical hepatectomy has been performed for hepatocellular carcinoma;
- The hepatocellular carcinoma has been confirmed by pathological examination;
- Barcelona clinic liver cancer(BCLC) stage A or B;
- Not receiving any preoperative anticancer drug;
- The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin≤2ULN, serum creatinine <1.5 ULN;
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- Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb≥9g/dl, platelet count≥60×109/L, absolute neutrophil count>1.0×109/L;
- The expected survival time ≥ 12 weeks;
- The subjects volunteer to sign the informed consent.
Who cannot join
- Hepatocellular carcinoma patients who received non-radical hepatectomy;
- Non-hepatocellular carcinoma patients;
- Those with Child-Pugh C;
- Pregnant or lactating women;
- Those with active bleeding due to various reasons;
- Those with HIV infection or AIDS-associated diseases;
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- Those with severe acute and chronic diseases;
- Those with severe diabetes;
- Those with serious infectious diseases;
- Those who can not take drugs by oral route;
- Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
- Conditions that are considered not suitable for this study investigators
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.
Read the detailed description
A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.
- Conditions
- Hepatic Carcinoma
- Being tested
- Huaier Granule
- Keywords
- Huaier Granule;, After radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier GranuleDrug
Also called Huaier
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
| Study group | Role | What they receive |
|---|---|---|
| Huaier Granule group | Experimental | Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd..
Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule. Receives: Drug: Huaier Granule |
| Bank-control group | No intervention | Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents. During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Recurrence and Metastasis After Hepatectomy
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
Measured: Week 94 after took medicine
Secondary outcomes (1)
Postoperative Survival Period
Assess Postoperative survival period
Measured: Week 94 after took medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startAug 2011
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic CarcinomaStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,044 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huazhong University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Xiaoping Chen, Professor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770431
- Sponsor's protocol ID
- HE-201101
- Status last verified
- Mar 2017
- First submitted
- 1 Jan 2013
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.
PubMed 29802174
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
- ClinicalTrials.gov ID
- NCT01770431
- Acronym / sponsor ID
- HE-201101
- Conditions
- Hepatic Carcinoma
- Keywords
- Huaier Granule;, After radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,044 participants (actual)
- Lead sponsor
- Qidong Gaitianli Medicines Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Huazhong University of Science and Technology
- Study start
- Aug 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Posted 2 Oct 2017
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 after radical hepatectomy.
Detailed description
A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier Granule group | Experimental | Drug: Huaier GranuleHuaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd.. Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule. |
| Bank-control group | No intervention | –Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents. During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: ≥ 18 and ≤ 75 years, both male and female;
- Radical hepatectomy has been performed for hepatocellular carcinoma;
- The hepatocellular carcinoma has been confirmed by pathological examination;
- Barcelona clinic liver cancer(BCLC) stage A or B;
- Not receiving any preoperative anticancer drug;
Key exclusion criteria (12 listed)
- Hepatocellular carcinoma patients who received non-radical hepatectomy;
- Non-hepatocellular carcinoma patients;
- Those with Child-Pugh C;
- Pregnant or lactating women;
- Those with active bleeding due to various reasons;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier GranuleAlso: HuaierHuaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po. | Drug | Huaier Granule group |
Primary outcome
Incidence of Recurrence and Metastasis After Hepatectomy
Time frame: Week 94 after took medicine
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
1 secondary outcome
Postoperative Survival Period
Time frame: Week 94 after took medicine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29802174Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.
- Individual participant dataSharing planned: Undecided
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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.
Xiaoping Chen, Professor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier Granule in people with Hepatic Carcinoma, run by Qidong Gaitianli Medicines Co., Ltd at 1 site 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 12 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: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Recurrence and Metastasis After Hepatectomy (time frame: Week 94 after took medicine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01770431, which also lists 1 linked publication.
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 2 Oct 2017.