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

Q

Qidong Gaitianli Medicines

Status and phase

Terminated
Phase 4

Conditions

Hepatic Carcinoma

Treatments

Drug: Huaier Granule

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01760616
HE-201102

Details and patient eligibility

About

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

Full 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.

Enrollment

790 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

790 participants in 2 patient groups

Test group
Experimental group
Description:
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
Treatment:
Drug: Huaier Granule
Control group: adjuvant therapy
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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