Carcinoma, Hepatocellular
Conditions
Keywords
HCC, TACE, Thermal Ablation, Safety/Efficacy
Brief summary
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.
Detailed description
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (\>5cm in diameter) and huge HCC (\>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
Interventions
PROCEDUREThermal Ablation
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
DRUGEADM
EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
Sponsors
Xijing Hospital
Changhai Hospital
Eastern Hepatobiliary Surgery Hospital
Shanghai Cancer Hospital, China
Shengjing Hospital
The Third Affiliated Hospital of Harbin Medical University
Jilin Provincial Tumor Hospital
Zhejiang Cancer Hospital
Jiangsu Cancer Institute & Hospital
Guangdong Provincial People's Hospital
Sichuan Cancer Hospital and Research Institute
Henan Cancer Hospital
Anhui Provincial Hospital
The First Affiliated Hospital of Anhui Medical University
Qilu Hospital of Shandong University
Shandong Tumor Hospital
First Affiliated Hospital of Xinjiang Medical University
Chinese PLA General Hospital
Nanfang Hospital, Southern Medical University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
LanZhou University
Sun Yat-sen University
Hunan Provincial People's Hospital
Affiliated Zhongshan Hospital of Dalian University
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months; 2. Patients with large HCC (\>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC); 3. Patients with no thrombus in main portal vein (PV) 4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2; 5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy; 6. White blood cell count ≥ 3.0×10\^9/L; 7. Hemoglobin ≥ 8.5g/dl; 8. Platelet ≥ 50×10\^9/L; 9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds; 10. Blood creatinine less than 1.5 times of upper limit of reference; 11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.
Exclusion criteria
1. Patients with diffuse type of liver cancer; 2. Cholangiocellular carcinoma 3. Patients with main PV thrombus; 4. Patients with hepatic vein thrombus; 5. Patients with lymph node or distant metastasis outside of liver; 6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection; 7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency; 8. Patients with intractable massive ascites; 9. Patients' ECOG PS \>2; 10. Patients complicated with active infection, especially cholangitis; 11. Patients with severe disorders of heart, lungs, kidneys, or brain; 12. Patients and/or their relatives refuse to anticipate this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | From the date of randomization until the date of death from any cause, assessed up to 26 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-Disease Progression | From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months | TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression. |
| Objective response rate (ORR) | Six months after the date of first procedure of TACE or TACE combined with synchronous ablation. | The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST) |
| Progression free survival(PFS) | From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months. | — |
| Numbers of TACE and TACE combined with ablation cycles | From the date of randomization until the date of death, assessed up to 26 months. | The times of the subjects undergoing TACE or TACE combined with ablation |
| Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups | From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation) | Serious or mild adverse events after treatment |
Countries
China
Contacts
Primary ContactJianhua Wang, MD
Backup ContactRong Liu, MD
Outcome results
None listed