Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

NCT01770431 | Completed Phase 4 Results DMC

• 1 other identifier: HE-201101
• Study Type: interventional
• Target: 1,044
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.

Conditions

Hepatic Carcinoma

Keywords

Huaier Granule;; After radical hepatectomy;; Prevention of Recurrence and Metastasis;; Safety.

Outcome Measures

Primary Outcomes (1)

• Incidence of Recurrence and Metastasis After Hepatectomy

  At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.

  Week 94 after took medicine

Secondary Outcomes (1)

• Postoperative Survival Period

  Week 94 after took medicine

Study Arms (2)

Huaier Granule group

EXPERIMENTAL

Huaier Granule group; specifications: 20g / bag; manufacturer: Qidong Gaitianli Medicines Co., Ltd.. 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 96 weeks after surgery or until study termination. The subjects should not take any other anticancer drugs or immunomodulatory agents, except for Huaier Granule.

Drug: Huaier Granule

Bank-control group

NO INTERVENTION

Blank-control group, not taking Huaier Granule, other anticancer drugs, or immunomodulatory agents. During the study, patients who need antiviral therapy, in both the test group and control group, can be treated according to the therapeutic principles.

Interventions

Huaier Granule DRUG

Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.

Also known as: Huaier

Huaier Granule 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;
• Radical hepatectomy has been performed for hepatocellular carcinoma;
• The hepatocellular carcinoma has been confirmed by pathological examination;
• Barcelona clinic liver cancer(BCLC) stage A or B;
• Not receiving any preoperative anticancer drug;
• 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≤2ULN, 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, absolute neutrophil count\>1.0×109/L;
• The expected survival time ≥ 12 weeks;
• The subjects volunteer to sign the informed consent.

You may not qualify if:

• Hepatocellular carcinoma patients who received non-radical hepatectomy;
• Non-hepatocellular carcinoma patients;
• Those with Child-Pugh C;
• Pregnant or lactating women;
• Those with active bleeding due to various reasons;
• Those with HIV infection or AIDS-associated diseases;
• Those with severe acute and chronic diseases;
• Those with severe diabetes;
• Those with serious infectious diseases;
• Those who can not take drugs by oral route;
• 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 University of Science and Technology

Wuhan, Hubei, China

Location

Related Publications (1)

• Chen Q, Shu C, Laurence AD, Chen Y, Peng BG, Zhen ZJ, Cai JQ, Ding YT, Li LQ, Zhang YB, Zheng QC, Xu GL, Li B, Zhou WP, Cai SW, Wang XY, Wen H, Peng XY, Zhang XW, Dai CL, Bie P, Xing BC, Fu ZR, Liu LX, Mu Y, Zhang L, Zhang QS, Jiang B, Qian HX, Wang YJ, Liu JF, Qin XH, Li Q, Yin P, Zhang ZW, Chen XP. Effect of Huaier granule on recurrence after curative resection of HCC: a multicentre, randomised clinical trial. Gut. 2018 Nov;67(11):2006-2016. doi: 10.1136/gutjnl-2018-315983. Epub 2018 May 25.

  PMID: 29802174 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Neoplasm Metastasis

Interventions

huaier

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Xiaoping Chen, Professor
• Organization: Huazhong University of Science and Technology, Tongji Hospital Affiliated to Tongji Medical College, Huazhong Wuhan, Hubei, China

chenxp@medmail.com.cn

+86 27 83663400

Study Officials

• Xiaoping Chen, Professor

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2013
• First Posted: January 17, 2013
• Study Start: August 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 2, 2017
• Results First Posted: October 2, 2017

Record last verified: 2017-03

Locations

CN (1)