Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Hepatic Carcinoma Clinical Trial

Official title:

A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760616
• Other study ID #: HE-201102
• Status: Terminated
• Phase: Phase 4
• Start date: November 7, 2011
• Est. completion date: June 30, 2017

Study information

• Verified date: March 2020
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Description:

A Prospective, Multicenter, Open-labeled, Parallel -controlled Clinical Study, to evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 790
• Est. completion date: June 30, 2017
• Est. primary completion date: August 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age: = 18 and = 75 years, both male and female;

2. Non-radical hepatectomy has been performed for hepatocellular carcinoma;

3. The hepatocellular carcinoma has been confirmed by pathological examination;

4. The liver and kidney function satisfies the following conditions within 15 days after surgery (excluding day 15): aspartate aminotransferase(AST), glutamic-oxalacetic transaminase(ALT)<3 upper limit of normal(ULN), total bilirubin =2 ULN, serum creatinine <1.5 ULN;

5. Other laboratory tests meet the following requirements within 15 days after surgery (excluding day 15): Hb=9g/dl, platelet count=60×109/L, neutrophil count> 1.5×109/L;

6. The expected survival time =12 weeks;

7. The subjects volunteer to sign the informed consent.

Exclusion Criteria:

1. Non-hepatocellular carcinoma patients;

2. Those who received radical hepatectomy;

3. Those with hepatic decompensation;

4. Pregnant or lactating women;

5. Those with HIV infection or AIDS-associated diseases;

6. Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;

7. Those who can not take drugs by oral route; or those develop serious adverse drug reaction;

8. Drug abusers or those with psychological or mental diseases that may interfere with study compliance;

9. Conditions that are considered not suitable for this study investigators.

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Disease Progression
• Hepatic Carcinoma

Intervention

Drug:
• Huaier Granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..

Locations

Country	Name	City	State
China	Tongji Hospital Affiliated to Tongji Medical College, Huazhong	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd	Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to significant progression after surgery and postoperative survival period.	Time to significant progression after surgery, including recurrence of local tumor, intrahepatic and extrahepatic metastasis, etc; and to evaluation of postoperative survival period.	3 years
Secondary	ECOG and QLQ-C30 scores	On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, assess the scores of Eastern Cooperative Oncology Group(ECOG) and quality of life questionnaire(QLQ)-C30 scale.	Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Secondary	Iconography assessment	On week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, give examination of B ultrasonic for Liver, X-ray for chest. If there is a suspected recurrence or metastases, will give enhancement CT/MRI examination for liver and chest; if no recurrence or metastases, will at least give enhancement CT/MRI examination for liver and chest every year.	Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Secondary	Alpha-fetoprotein quantitation and related biochemical indicators	On week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132 and 144, monitor Alpha-fetoprotein quantitation.	Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144