Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy
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|ClinicalTrials.gov Identifier: NCT02399033|
Recruitment Status : Unknown
Verified February 2015 by Shuqun Cheng, Eastern Hepatobiliary Surgery Hospital.
Recruitment status was: Recruiting
First Posted : March 26, 2015
Last Update Posted : March 26, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Xihuang Capsules||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Xihuang Capsules Prevention of Recurrence in Patients With Hepatocellular Carcinoma After Hepatectomy: A Multicenter Randomized Controlled Trial|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
No Intervention: the control group
Patients in Control group were not received Xihuang Capsules.
Experimental: Xihuang Capsules group
Patients in Xihuang Capsules group were received Xihuang Capsules (2g, bid), Continuously taking to cancer recurrence or death.
Drug: Xihuang Capsules
In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death.
Other Name: Wangbang Pharmaceutical Xihuang Capsules
- 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.
- 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 ]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 [ Time Frame: in a year or three years after hepatectomy ]
- Overall survival(OS) [ Time Frame: up to 5 years ]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 [ Time Frame: 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. [ Time Frame: participants will be followed for the duration of study, an expected average of 3 months. ]
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. [ Time Frame: up to 5 years ]Classification according to the Common Terminology Criteria Adverse Events Version 4.0(CTCAE v4.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02399033
|Contact: Shuqun Cheng, Ph.D||021-65564166|
|Eastern Hepatobiliary Surgical Hospital||Recruiting|
|Shanghai, Shanghai, China, 200438|
|Contact: Shuqun Cheng, Ph.D 021-65564166|
|Principal Investigator:||Shuqun Cheng, Ph.D||Eastern Hepatobiliary Surgical Hospital|