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

NCT01760616 | Terminated Phase 4 DMC

• 1 other identifier: HE-201102
• Study Type: interventional
• Target: 790
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Carcinoma

Keywords

Huaier Granule;; After non-radical hepatectomy;; Prevention of Disease Progression of Hepatocarcinoma;; Safety.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ECOG and QLQ-C30 scores

  Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Iconography assessment

  Week 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144

• Alpha-fetoprotein quantitation and related biochemical indicators

  Week 8, 16, 24, 32, 40, 48, 60, 72, 84, 96, 108, 120, 132, 144

Study Arms (2)

Test group

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

Drug: Huaier Granule

Control group: adjuvant therapy

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.

Interventions

Huaier Granule DRUG

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

Test group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 and ≤ 75 years, both male and female;
• Non-radical hepatectomy has been performed for hepatocellular carcinoma;
• The hepatocellular carcinoma has been confirmed by pathological examination;
• 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;
• 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;
• The expected survival time ≥12 weeks;
• The subjects volunteer to sign the informed consent.

You may not qualify if:

• Non-hepatocellular carcinoma patients;
• Those who received radical hepatectomy;
• Those with hepatic decompensation;
• Pregnant or lactating women;
• Those with HIV infection or AIDS-associated diseases;
• Those with severe acute and chronic diseases, such as infection, diabetes cardiac insufficiency, pulmonary insufficiency, renal insufficiency;
• Those who can not take drugs by oral route; or those develop serious adverse drug reaction;
• Drug abusers or those with psychological or mental diseases that may interfere with study compliance;
• Conditions that are considered not suitable for this study investigators.

Sponsors & Collaborators

• Qidong Gaitianli Medicines Co., Ltd: lead
• Huazhong University of Science and Technology: collaborator

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College, Huazhong

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Xiaoping Chen, Professor

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2013
• First Posted: January 4, 2013
• Study Start: November 7, 2011
• Primary Completion: August 15, 2015
• Study Completion: June 30, 2017
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

CN (1)