| Study name |
Combine TACE and RFA versus TACE alone for HCC with PVTT (CORTT) |
| Methods |
Interventional (clinical trial) |
| Participants |
Inclusion Criteria:
HCC with portal vein tumour thrombus in the first or second branch Refused sorafenib or could not tolerate the adverse effect of sorafenib A solitary HCC ≤ 5.0 cm in diameter, or multiple HCC ≤ 3 lesions, each ≤ 5.0 cm in diameter Eastern Cooperative Oncology Group Performance Status 0‐1 Child‐Pugh Score ≤ 8 Platelet counts of > 60,000/mm3, haemoglobin > 8.5 g/dL, prothrombin time prolonged < 6s Albumin > 2.8 g/dL, total bilirubin < 51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST) < 5 times of upper limit Signed informed consent
Exclusion Criteria:
Presence of extrahepatic metastasis except lymph node metastasis The blood supply of tumour lesions is absolutely poor or arterial‐venous shunt that TACE can not be performed Uncontrolled or refractory ascites, ongoing variceal bleeding or encephalopathy Severe heart, brain or kidney diseases Previous or concurrent cancer that is distinct in primary site or histology from HCC Pregnant women or lactating women
|
| Interventions |
Experimental: TACE‐RFA
2 sessions of TACE first, RFA for residual viable tumours and PVTT within 1 month
Active Comparator: TACE alone
Repeated TACE and 1 to 2 months interval between two sessions of TACE |
| Outcomes |
Primary outcome measures:
Overall survival rates [time frame: 1 year]
Secondary outcome measures:
Progression‐free survival rates [time frame: 6 months] Response rate of PVTT [time frame: 6 months] Number of participants with adverse events [time frame: 1 month]
|
| Starting date |
October 2014 |
| Contact information |
Ming Zhao, doctor +86 020 87343272zhaoming@sysucc.org.cn
|
| Notes |
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