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There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, While this group of patients are classified as hepatectomy contraindication according to guidelines from National Comprehensive Cancer Network (NCCN) and American Association for the Study of Liver Diseases (AASLD). With improvement of surgical technique, preoperative evaluation, and perioperative management,especially the Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal hypertension.However, most of the previous studies were either retrospective or with small samples.
The investigators project is a prospective randomized controlled trial, planning to compare the safety, efficacy and quality of life between precise hepatectomy and combined interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, to make a further understanding of optimal strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgery | Experimental | Precise hepatectomy |
|
| combined intervention | Active Comparator | transcatheter hepatic arterial chemoembolization and/or ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precise hepatectomy | Procedure | Precise hepatectomy |
| |
| Combined intervention (chemoembolization/ablation) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment complication | defined as complications within the 90 days after treatment | 90 days |
| Time to progress(TTP) | TTP: The Hazard Ratio will be analyzed respectively with 95% confidence interval. Meanwhile, Kaplan-Meier estimation and survival curves will be performed. |
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Inclusion Criteria:
Diagnosis of hepatocellular carcinoma patients, in accordance with HCC Professional Committee of the Chinese Anti-Cancer Association 2001 "Clinical Diagnosis of Primary Liver Cancer and Staging Criteria"
solitary tumor ≤5cm, or three or fewer lesions none ≤3cm,As Milan criteria
History of hepatitis B or HBsAg positive
Cirrhosis and portal hypertension
No treatment on liver cancer before
KPS score ≥ 70
The age of 18 to 65 years
Child-Pugh A or B (Class B, scoring no more than 7 points)
Baseline laboratory test comply with the following criteria:
Informed consent with signature and time
Good patient compliance
The surgical group patients received radical hepatectomy. Radical surgery is defined as: complete resection of visible tumor, R0 resection margins, and also including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunfei Yuan | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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transartery embolization chemotherapy, infusion of Chemoembolization was performed using 30 mg/m2 of epirubicin, 200 mg/m2 of carboplatin, and 4mg/m2 of mitomycin C (MMC), mixed with 2-5 mL lipiodol. Then up to 20 mL of additional pure lipiodol was injected into the tumor-feeding artery until stasis of blood flow in the target artery was observed
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| Other |
transcatheter hepatic arterial chemoembolization and/or ablation |
|
| 3 years |
| Disease control rate(DCR) | Disease control rate: Calculate the disease control rate of the two treatment groups (disease control rate) and its 95% confidence interval, and make a descriptive analysis. | 3 years |
| Quality of life(Qol) | Quality of life: Follow the QOL-LC V2.0 | 5 years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |