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

NCT02399033 | Unknown Phase 4

• 1 other identifier: SCheng
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Xihuang Capsules; hepatocellular carcinoma; Recurrence; hepatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Hepatocellular carcinoma recurrence rate in a year after hepatectomy

  in a year after hepatectomy

• Relapse free survival (RFS)

  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)

  up to 5 years

• Improvement in quality of life in a year or three years after hepatectomy

  in a year or three years after hepatectomy

Study Arms (2)

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.

Drug: Xihuang Capsules

Interventions

Xihuang Capsules DRUG

In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death.

Also known as: Wangbang Pharmaceutical Xihuang Capsules

Xihuang Capsules group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shuqun Cheng: lead

Study Sites (1)

Eastern Hepatobiliary Surgical Hospital

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Recurrence

Interventions

xihuang

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shuqun Cheng, Ph.D

  Eastern Hepatobiliary Surgical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuqun Cheng, Ph.D

CONTACT

021-65564166

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xihuang Capsules prevention of recurrence in patients with hepatocellular carcinoma after hepatectomy: A multicenter randomized controlled trial.

Study Record Dates

• First Submitted: February 12, 2015
• First Posted: March 26, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 26, 2015

Record last verified: 2015-02

Locations

CN (1)