This is a phase I/II dose-escalation study of lipotecan based concurrent chemoradiotherapy in hepatocellular carcinoma with portal vein tumor thrombosis.
Protocol number: TLCTLC388A1008 Primary objective: To evaluate the safety and tolerability, including maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), of Lipotecan based concurrent chemoradiotherapy (CCRT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) unsuitable for local treatment. Secondary Objective: The secondary objective is to explore the efficacy of Lipotecan based CCRT in patients with HCC and PVTT and the effect on quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Lipotecan based concurrent chemoradiotherapy
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hosipital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Maximum tolerated dose determination for Lipotecan based CCRT
To determine maximum tolerated dose for Lipotecan based CCRT in HCC patients with portal vein tumor thrombosis
Time frame: 3 months
Best objective response evaluation of portal vein tumor thrombosis
To evaluate the best objective response rate of portal vein tumor thrombosis
Time frame: 1 year
Conversion rate (CR) of portal vein tumor thrombosis
To evaluate the conversion rate (CR rate) of PVTT
Time frame: 1 year
Best overall response of overall disease
To evaluate the best overall response rate of overall disease
Time frame: 1 year
Disease control rate of portal vein tumor thrombosis, liver tumors and overall disease
To evaluate DCR of PVTT, liver tumors (target lesions), and overall disease
Time frame: 1 year
Time to progression of overall disease
To evaluate the TTP of overall disease after the start of concomitant Lipotecan based CCRT
Time frame: 1 year
Progression free survival of overall disease
To evaluate the PFS of overall disease after the start of concomitant Lipotecan based CCRT
Time frame: 1 year
Overall survival of overall disease
To evaluate the OS after the start of concomitant Lipotecan based CCRT
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Time frame: 1 year