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Completed

NCT Number: NCT01770431

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

About this study

A Multicenter, Randomized, Paralleled control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma after Radical Hepatectomy,to evaluate the efficacy and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Huaier granule

Drug

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

Other names: Huaier

Primary outcomes

  1. Incidence of Recurrence and Metastasis After Hepatectomy

    Time frame: Week 94 after took medicine

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

Secondary outcomes

  1. Postoperative Survival Period

    Time frame: Week 94 after took medicine

    Assess Postoperative survival period

Sponsors and collaborators

Lead sponsor

Qidong Gaitianli Medicines Co., Ltd

Industry

Collaborators

  • Huazhong University of Science and Technology

Registry information

Official study title

A Multicenter, Randomized, Paralleled Control Clinical Study Investigating Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2013
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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