Hepatic Carcinoma
Conditions
Keywords
Huaier Granule;, After radical hepatectomy;, Prevention of Recurrence and Metastasis;, Safety.
Brief summary
To evaluate the efficacy and safety of Huaier Granule for prevention of recurrence and metastasis of hepatocarcinoma after radical hepatectomy.
Detailed description
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.
Interventions
DRUGHuaier Granule
Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
Sponsors
Huazhong University of Science and Technology
Qidong Gaitianli Medicines Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Recurrence and Metastasis After Hepatectomy | Week 94 after took medicine | At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Survival Period | Week 94 after took medicine | Assess Postoperative survival period |
Countries
China
Participant flow
Recruitment details
Patients were recruited from 39 hospitals in China between December 7, 2011 and December 31, 2014. 1044 patients met eligibility criteria and were randomly assigned at a 2:1 ratio: 696 in Huaier group and 348 patients in the blank control group.
Participants by arm
| Arm | Count |
|---|---|
| Huaier Granule Group 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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po. | 686 |
| Bank-control Group 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.
Huaier Granule: Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po. | 316 |
| Total | 1,002 |
Baseline characteristics
| Characteristic | Huaier Granule Group | Bank-control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 113 Participants | 41 Participants | 154 Participants |
| Age, Categorical Between 18 and 65 years | 573 Participants | 275 Participants | 848 Participants |
| Number of tumor Multiple tumors | 91 Participants | 42 Participants | 133 Participants |
| Number of tumor Single tumor | 595 Participants | 274 Participants | 869 Participants |
| Region of Enrollment China | 686 Participants | 316 Participants | 1002 Participants |
| Sex: Female, Male Female | 121 Participants | 61 Participants | 182 Participants |
| Sex: Female, Male Male | 565 Participants | 255 Participants | 820 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 35 / 686 | 6 / 316 |
| serious Total, serious adverse events | 0 / 686 | 0 / 316 |
Outcome results
Primary
Incidence of Recurrence and Metastasis After Hepatectomy
At week 94 after took medicine, assess incidence of recurrence and metastasis after hepatectomy.
Time frame: Week 94 after took medicine
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Huaier Granule Group | Incidence of Recurrence and Metastasis After Hepatectomy | Recurrence-free | 428 Participants |
| Huaier Granule Group | Incidence of Recurrence and Metastasis After Hepatectomy | Recurrence | 258 Participants |
| Bank-control Group | Incidence of Recurrence and Metastasis After Hepatectomy | Recurrence-free | 155 Participants |
| Bank-control Group | Incidence of Recurrence and Metastasis After Hepatectomy | Recurrence | 161 Participants |
p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Postoperative Survival Period
Assess Postoperative survival period
Time frame: Week 94 after took medicine
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Huaier Granule Group | Postoperative Survival Period | 75.5 weeks | Standard Error 1.15 |
| Bank-control Group | Postoperative Survival Period | 68.5 weeks | Standard Error 1.89 |
p-value: <0.000195% CI: [0.55, 0.81]Regression, Cox