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Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy

Primary Purpose

Hepatocellular Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xihuang Capsules
Sponsored by
Shuqun Cheng
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hepatocellular Carcinoma focused on measuring Xihuang Capsules, hepatocellular carcinoma, Recurrence, hepatectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 20-70 years old;
  2. Gender: male or female;
  3. clinical or pathological diagnosis of hepatocellular carcinoma (HCC) in previously untreated patients;
  4. The expected survival> 3 months;
  5. Child-Pugh grade in A-level;
  6. KPS score with 50-100 points;

  7. 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.
  8. women in the reproductive period must be completely contraception in 28 days before treatment, during the treatment process and in 28 days after treatment;
  9. Men must be completely contraception and prohibited donation and sperm donation during the treatment process and in 28 days after treatment;
  10. All patients must be prohibited donation during the treatment process and in 28 days after treatment;
  11. In addition to the subjects, prohibitting other people taking this product.
  12. patients have a good understanding and could coordinate with investigators for the trial.
  13. 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.

Exclusion Criteria:

  1. Because of suffering from any serious illness,laboratory abnormalities or mental abnormalities,the patient is unable to sign an informed consent form;
  2. patients with medical abnormalities may result in that the trial could not be evaluated or have security risks;
  3. persons who are unable to take oral drugs.
  4. coagulation dysfunction;
  5. HIV, syphilis-infected persons;
  6. persons who have a serious heart, liver and renal failure;
  7. persons who are known to allergic to the drug or any component of the drug;
  8. persons who are received experimental therapy in 28 days before the first treatment;
  9. 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;
  10. lactating or pregnant women;
  11. patients in the reproductive period are unwilling or unable to contraception;
  12. persons with poor medication compliance;
  13. The researchers considered unsuitable selected patients.

Sites / Locations

  • Eastern Hepatobiliary Surgical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

the control group

Xihuang Capsules group

Arm Description

Patients in Control group were not received Xihuang Capsules.

Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Hepatocellular carcinoma recurrence rate 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.
Hepatocellular carcinoma survival rate 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.
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.
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.
The incidence of adverse reaction.
Classification according to the Common Terminology Criteria Adverse Events Version 4.0(CTCAE v4.0).

Full Information

First Posted
February 12, 2015
Last Updated
March 22, 2015
Sponsor
Shuqun Cheng
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1. Study Identification

Unique Protocol Identification Number
NCT02399033
Brief Title
Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy
Official Title
Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shuqun Cheng

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Xihuang Capsules, hepatocellular carcinoma, Recurrence, hepatectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the control group
Arm Type
No Intervention
Arm Description
Patients in Control group were not received Xihuang Capsules.
Arm Title
Xihuang Capsules group
Arm Type
Experimental
Arm Description
Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death.
Intervention Type
Drug
Intervention Name(s)
Xihuang Capsules
Other Intervention Name(s)
Wangbang Pharmaceutical Xihuang Capsules
Intervention Description
In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death.
Primary Outcome Measure Information:
Title
Hepatocellular carcinoma recurrence rate in the three years after hepatectomy
Description
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.
Time Frame
in the three years after hepatectomy
Secondary Outcome Measure Information:
Title
Hepatocellular carcinoma recurrence rate in a year after hepatectomy
Time Frame
in a year after hepatectomy
Title
Relapse free survival (RFS)
Description
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.
Time Frame
up to 5 years
Title
Hepatocellular carcinoma survival rate in a year or three years after hepatectomy
Time Frame
in a year or three years after hepatectomy
Title
Overall survival(OS)
Description
OS is defined as from date of randomization until the date of documented death from any cause.
Time Frame
up to 5 years
Title
Improvement in quality of life in a year or three years after hepatectomy
Description
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.
Time Frame
in a year or three years after hepatectomy
Title
number of participants with improvement of clinical symptoms, Such as flank pain, bloating, fatigue, anorexia and other syndromes of traditional Chinese Medicine.
Description
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.
Time Frame
participants will be followed for the duration of study, an expected average of 3 months.
Title
The incidence of adverse reaction.
Description
Classification according to the Common Terminology Criteria Adverse Events Version 4.0(CTCAE v4.0).
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuqun Cheng, Ph.D
Phone
021-65564166
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuqun Cheng, Ph.D
Organizational Affiliation
Eastern Hepatobiliary Surgical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Hepatobiliary Surgical Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuqun Cheng, Ph.D
Phone
021-65564166

12. IPD Sharing Statement

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Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy

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