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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xihuang Capsules | Drug | In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | in the three years after hepatectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatocellular carcinoma recurrence rate in a year after hepatectomy | 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. |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuqun Cheng, Ph.D | Contact | 021-65564166 |
| Name | Affiliation | Role |
|---|---|---|
| Shuqun Cheng, Ph.D | Eastern Hepatobiliary Surgical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Hepatobiliary Surgical Hospital | Recruiting | Shanghai | Shanghai Municipality | 200438 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000598753 | xihuang |
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|
| up to 5 years |
| Hepatocellular carcinoma survival rate in a year or three years after hepatectomy | 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. | 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. | 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. | 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). | up to 5 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |