Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

NCT01642446 | Completed DMC

• 1 other identifier: 20125010Y
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma(HCC); Cirrhotic Portal Hypertension

Keywords

precise hepatectomy; hepatocellular carcinoma; cirrhotic; portal hypertension; safety; combined interventional treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Treatment complication

  90 days

• Time to progress(TTP)

  3 years

• Disease control rate(DCR)

  3 years

• Quality of life(Qol)

  5 years

Study Arms (2)

surgery

EXPERIMENTAL

Precise hepatectomy

Procedure: Precise hepatectomy

combined intervention

ACTIVE COMPARATOR

transcatheter hepatic arterial chemoembolization and/or ablation

Other: Combined intervention (chemoembolization/ablation)

Interventions

Precise hepatectomy PROCEDURE

Precise hepatectomy

surgery

Combined intervention (chemoembolization/ablation) OTHER

transcatheter hepatic arterial chemoembolization and/or ablation

combined intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• White blood cell ≥ 1.0×109/L
• Platelet ≥ 25×109/L
• Hemoglobin ≥ 80g/L
• Serum ALT,AST ≤ 3×upper limit of normal (ULN)
• Serum creatinine ≤ 1.5 × ULN
• INR\<1.5, or prothrombin time \<ULN +4 sec

You may not qualify if:

• extrahepatic metastasis; With metastasis in major branch of portal vein, hepatic vein
• History of hepatitis C or HCV-Ab positive
• Pugh Child-Pugh C, or with massive ascites or had a history of hepatic encephalopathy, or Upper digestive tract bleeding
• Poor physical condition or cachexia
• During the past 12 months just before the study, there had been any of the following: myocardial infarction, severe/unstable angina, coronary artery bypass graft surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; arrhythmia according to the NCI-CTCAE ≥ grade 2, QTc interval extension (male\> 450 ms, female\> 470 ms);
• Renal insufficiency, need peritoneal dialysis or hemodialysis
• Serious dysfunction of other organs
• History of second primary malignant tumors
• Known or new evidence of brain or leptomeningeal disease
• Hemophilia or bleeding tendency, and are taking therapeutic doses of coumarin derivative anticoagulant therapy drugs
• Pregnant or lactation, all female patients with childbearing potential must have a pregnancy test (serum or urine) within 7 days after enrollment,and the result is negative
• History of organ transplantation
• Known HIV infection
• With any other serious acute and chronic physical or mental disease or abnormal laboratory tests, which are likely to increase risks or interfere with the interpretation of the results, or researchers believe that patients are not suitable for enrollment

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Hypertension, Portal

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Yunfei Yuan

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: 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

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 17, 2012
• Study Start: January 1, 2013
• Primary Completion: December 30, 2018
• Study Completion: August 30, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CN (1)