Status:
UNKNOWN
Radiofrequency Ablation Accompanied With Spontaneous Sorafenib in Early to Intermediate Stage HCC
Lead Sponsor:
Southwest Hospital, China
Conditions:
HCC
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Radiofrequency ablation (RFA)can be curative with small localized HCCs up to 5 cm in diameter. However, the long-term prognosis is not satisfactory due to the high incidence of recurrence.Multimodalit...
Detailed Description
Radiofrequency ablation (RFA) has been used as a minimally invasive option to eradicate tumors and preserve liver function in patients with impaired function or with a postoperative tumor recurrence. ...
Eligibility Criteria
Inclusion
- Authorization of Informed Consent
- HCC diagnosed by biopsy or Image findings
- BCLC stage 0 to B1
- This time was the primary treatment of HCC. Had no history of any tumor specific therapy,including RFA,Hepatectomy,TACE,HIFU,and Transplantation
- Child Pugh A or B
- ECOG 0 to 2
- single lesion less than or equal to 5 cm,2 to 3 nodules, maximal size less than equal to 3cm
- Male or female (without pregnancy)
- Ages between 18 to 70 years
- Capable of take medicines
- anticipate at least survival of 12 weeks
- Unwilling to receive surgical resection or liver transplantation
- Potentially curable disease by RFA
- Sorafenib administrated less than 4 weeks before or after RFA procedures
- For any excuse,subject should take Sorafenib at least for 4 weeks
Exclusion
- A cancer embolus in major hepatic vessels or extrahepatic metastases
- Tumor number more than 4 or tumor size larger than 5 cm
- A present or past history of uncontrollable ascites, hepatic encephalopathy or variceal bleeding
- A history of a secondary malignancy
- Severe dysfunction of the heart, kidney or other organs
- Active infection except viral hepatitis
- Any treatment history of target lesion including chemotherapy and TACE
- Pregnancy
- received other trials on gene therapy
- have received operation less than 4 weeks
Key Trial Info
Start Date :
March 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT02187081
Start Date
March 15 2017
End Date
December 1 2018
Last Update
March 28 2017
Active Locations (1)
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1
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038