Overview

This trial is active, not recruiting.

Condition hepatic carcinoma
Treatment huaier granule
Phase phase 4
Sponsor Qidong Gaitianli Medicines Co., Ltd
Collaborator Huazhong University of Science and Technology
Start date August 2011
End date December 2018
Trial size 1680 participants
Trial identifier NCT01760616, HE-201102

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Test group: Adjuvant therapy + Huaier Granule group.Administration: the Huaier Granule Electuary should be orally taken from the 15th day after surgery. Usage: Huaier Granule Electuary is continuously taken three times per day, 20g per time, until 144 weeks after surgery or until study termination Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment
huaier granule
Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
(No Intervention)
Control group: adjuvant therapy Adjuvant therapy: the adjuvant therapies are not limited, and for example, all the following treatments can be applied according to the individual's condition and guidelines of the research center: ablation therapy, immunotherapy, chemotherapy, radiotherapy, and Chinese herbs, as well as programs and medications that are used for post-operative liver protection and antiviral treatment.

Primary Outcomes

Measure
Time to significant progression after surgery
time frame: 3 years

Secondary Outcomes

Measure
ECOG and QLQ-C30 scores
time frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Iconography assessment
time frame: Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144
Alpha-fetoprotein quantitation and related biochemical indicators
time frame: Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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> 2.5×109/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.

Additional Information

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
Principal investigator Xiaoping Chen, Professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Qidong Gaitianli Medicines Co., Ltd.