Clinical trial · Interventional
Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
A Prospective, Multicenter, Open-labeled, Parallel -Controlled Clinical Study Investigating Huaier Granule for Prevention of Disease Progression of Hepatocarcinoma After Non-radical Hepatectomy
NCT01760616CI-TRIAL-00043845terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): difficult to recruit patients
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Huaier Granule for prevention of disease progression of hepatocarcinoma after non-radical hepatectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Huaier Granule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test 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
- interventionNames
- Drug: Huaier Granule
- type
- NO_INTERVENTION
- label
- Control group: adjuvant therapy
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.