Phase 4
N=1,044
Huaier Granule for Prevention of Recurrence and Metastasis of Hepatocarcinoma After Radical Hepatectomy
Hepatic Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT01770431 ↗Enrolled (actual)
1,044
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Incidence of Recurrence and Metastasis After Hepatectomy — 428; 155; 258; 161 Participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Huaier Granule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Recurrence and Metastasis After Hepatectomy |
428; 155; 258; 161 | 0.0001 sig |
| SECONDARY Postoperative Survival Period |
75.5; 68.5 | <0.0001 sig |
Summary
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.
Eligibility Criteria
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) 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
Data sourced from ClinicalTrials.gov (NCT01770431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.