Hepatocellular CarcinomaPhase 4NCT02399033
Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy
A Phase 4 study testing Xihuang Capsules in people with Hepatocellular Carcinoma, run by Shuqun Cheng at 1 site in China.
Trial summary
Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy. Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group Clinical Trial. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Xihuang Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2019
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-70 years old;
- Gender: male or female;
- clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;
- The expected survival> 3 months;
- Child-Pugh grade in A-level;
- KPS score with 50-100 points;
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- In two weeks after hepatectomy for R0 resection surgery. Preoperative must meet the following criteria:
- BCLC stage of 0-B;
- conform to the indications of hepatectomy;
- Viable tumor resection confirmed by two highly qualified surgical doctors;
- No other surgical contraindications.
- women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;
- Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;
- All patients must be prohibited donation during the treatment process and in 28 days after treatment;
- In addition to the subjects, prohibitting other people taking this product.
- patients have a good understanding and could coordinate with investigators for the trial.
- Patients enrolled in the trial should sign an informed consent form, to indicate understanding the purpose and procedure of the trial, and patients volunteering to participate in the trial.
Who cannot join
- Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;
- patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;
- persons who are unable to take oral drugs.
- coagulation dysfunction;
- HIV, syphilis-infected persons;
- persons who have a serious heart, liver and renal failure;
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- persons who are known to allergic to the drug or any component of the drug;
- persons who are received experimental therapy in 28 days before the first treatment;
- persons who are received radiotherapy or other surgery(including of the other local surgery for cancer treatment,eg. TACE) in addition to hepatectomy in 14 days before the first treatment;
- lactating or pregnant women;
- patients in the reproductive period are unwilling or unable to contraception;
- persons with poor medication compliance;
- The researchers considered unsuitable selected patients.
Trial locations and contacts
1 site in 1 country.
Shuqun Cheng, Ph.D contact
China1 site, 1 recruiting
- Recruiting
Eastern Hepatobiliary Surgical Hospital
Shanghai, Shanghai Municipality, 200438
Shuqun Cheng, Ph.D, 021-65564166
About this study
Official title: Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy.
Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group or the control group by the proportion of 2: 1.
Read more
The total sample size: 1000 cases. Study Process: The study is divided into three phases: the screening phase, treatment phase, follow-up phase.To complete screening in two weeks, patients who fit the criteria were randomly assigned to Xihuang Capsules group or the control group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2g,bid), Continuously taking to cancer recurrence or death.Control group was not received Xihuang Capsules. In the first month to three years after treatment, Conducting visits for once every three months,to evaluate the efficacy and safety with hepatocellular carcinoma recurrence rate in the three years after hepatectomy as the primary outcome. When entering the follow-up phase, Keeping in touch with patients withdrew from the study for a clinic or telephone follow-up every three months.
From signing informed consent till the end of the study, inspecting the adverse events and concomitant medications for all subjects in each visit.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Xihuang Capsules
- Keywords
- Xihuang Capsules, hepatocellular carcinoma, Recurrence, hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xihuang CapsulesDrug
Also called Wangbang Pharmaceutical Xihuang Capsules
In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death.
| Study group | Role | What they receive |
|---|---|---|
| the control group | No intervention | Patients in Control group were not received Xihuang Capsules. |
| Xihuang Capsules group | Experimental | Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death. Receives: Drug: Xihuang Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
Diagnostic criteria for hepatocellular carcinoma recurrence: refer to Chinese Anti-Cancer Association Professional Committee of hepatocellular carcinoma developed diagnostic criteria for primary hepatocellular carcinoma belong to Guangzhou standard in 2001. Once new or suspected place nature lesions within liver were found by B-ultrasonography examination,we should do CT, MRI or PET-CT review, in order to confirm the diagnosis. If imaging is positive, diagnosing hepatocellular carcinoma(dominant) recurrence after treatment; if imaging is negative, but AFP values> 400μg/L or ongoing elevated AFP values, diagnosing hepatocellular carcinoma occult recurrence after treatment.
Measured: in the three years after hepatectomy
Secondary outcomes (7)
Hepatocellular carcinoma recurrence rate in a year after hepatectomy
Measured: in a year after hepatectomy
Relapse free survival (RFS)
RFS is defined as from date of randomization until the date of first documented tumor recurrence or date of death from any cause, whichever came first.
Measured: up to 5 years
Hepatocellular carcinoma survival rate in a year or three years after hepatectomy
Measured: in a year or three years after hepatectomy
Overall survival(OS)
OS is defined as from date of randomization until the date of documented death from any cause.
Measured: up to 5 years
Improvement in quality of life in a year or three years after hepatectomy
Using Karnofsky-Performance-Status score:
Evaluation Methods: Comparison of symptom scores before and after the treatment.
Markedly: increasing by more than 20 points after treatment compared to before treatment; Effective: increasing by more than 10 points after treatment compared to before treatment; Stable: increasing by less than 10 points or no change after treatment compared to before treatment; Invalid: decrease after treatment than before treatment.
Measured: in a year or three years after hepatectomy
number of participants with improvement of clinical symptoms, Such as flank pain, bloating, fatigue, anorexia and other syndromes of traditional Chinese Medicine.
Evaluation index : according to clinical observations, TCM symptoms are divided into 4 levels: (0) no symptoms, (1) mild, (2) moderate, (3)severe, Recording treatment according to symptoms.
Evaluation methods: comparison of symptom total integral before and after the treatment (before treatment / after treatment) Markedly: symptom disappeared, or symptom integral reduce ≥ 2/3; Effective: symptom alleviative, integral is reduced≥1/3，≤2/3; Invalid: symptom is not alleviated or reduced<1/3.
Measured: participants will be followed for the duration of study, an expected average of 3 months.
The incidence of adverse reaction.
Classification according to the Common Terminology Criteria Adverse Events Version 4.0(CTCAE v4.0).
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shuqun Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Shuqun Cheng, Ph.D, Principal investigator, Eastern Hepatobiliary Surgical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399033
- Sponsor's protocol ID
- SCheng
- Status last verified
- Feb 2015
- First submitted
- 12 Feb 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02399033
- Acronym / sponsor ID
- SCheng
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Xihuang Capsules, hepatocellular carcinoma, Recurrence, hepatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shuqun ChengUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- 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.
Study Objective: To evaluate the efficacy and safety of Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy.
Study Design: The study was A Multicenter, Randomized, Controlled, Open-Label, Parallel-Group Clinical Trial. Patients will be randomly assigned to Xihuang Capsules group or the control group by the proportion of 2: 1.
The total sample size: 1000 cases. Study Process: The study is divided into three phases: the screening phase, treatment phase, follow-up phase.To complete screening in two weeks, patients who fit the criteria were randomly assigned to Xihuang Capsules group or the control group.In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2g,bid), Continuously taking to cancer recurrence or death.Control group was not received Xihuang Capsules. In the first month to three years after treatment, Conducting visits for once every three months,to evaluate the efficacy and safety with hepatocellular carcinoma recurrence rate in the three years after hepatectomy as the primary outcome. When entering the follow-up phase, Keeping in touch with patients withdrew from the study for a clinic or telephone follow-up every three months.
From signing informed consent till the end of the study, inspecting the adverse events and concomitant medications for all subjects in each visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the control group | No intervention | –Patients in Control group were not received Xihuang Capsules. |
| Xihuang Capsules group | Experimental | Drug: Xihuang CapsulesPatients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age: 20-70 years old;
- Gender: male or female;
- clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;
- The expected survival> 3 months;
- Child-Pugh grade in A-level;
Key exclusion criteria (13 listed)
- Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;
- patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;
- persons who are unable to take oral drugs.
- coagulation dysfunction;
- HIV, syphilis-infected persons;
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 |
|---|---|---|
| Xihuang CapsulesAlso: Wangbang Pharmaceutical Xihuang CapsulesIn two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death. | Drug | Xihuang Capsules group |
Primary outcome
Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
Time frame: in the three years after hepatectomy
Diagnostic criteria for hepatocellular carcinoma recurrence: refer to Chinese Anti-Cancer Association Professional Committee of hepatocellular carcinoma developed diagnostic criteria for primary hepatocellular carcinoma belong to Guangzhou standard in 2001. Once new or suspected place nature lesions within liver were found by B-ultrasonography examination,we should do CT, MRI or PET-CT review, in order to confirm the diagnosis. If imaging is positive, diagnosing hepatocellular carcinoma(dominant) recurrence after treatment; if imaging is negative, but AFP values> 400μg/L or ongoing elevated AFP values, diagnosing hepatocellular carcinoma occult recurrence after treatment.
7 secondary outcomes
Hepatocellular carcinoma recurrence rate in a year after hepatectomy
Time frame: in a year after hepatectomy
Relapse free survival (RFS)
Time frame: up to 5 years
Hepatocellular carcinoma survival rate in a year or three years after hepatectomy
Time frame: in a year or three years after hepatectomy
Overall survival(OS)
Time frame: up to 5 years
Improvement in quality of life in a year or three years after hepatectomy
Time frame: in a year or three years after hepatectomy
number of participants with improvement of clinical symptoms, Such as flank pain, bloating, fatigue, anorexia and other syndromes of traditional Chinese Medicine.
Time frame: participants will be followed for the duration of study, an expected average of 3 months.
The incidence of adverse reaction.
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Shuqun Cheng, Ph.D contact
Shuqun Cheng, Ph.D principal investigator
Eastern Hepatobiliary Surgical Hospital
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 Xihuang Capsules in people with Hepatocellular Carcinoma, run by Shuqun Cheng 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 17 inclusion and 13 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 26 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuqun Cheng, Ph.D (021-65564166), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatocellular carcinoma recurrence rate in the three years after hepatectomy (time frame: in the three years after hepatectomy). 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 26 Mar 2015.