This is a prospective, randomized, controlled, exploratory Phase II clinical study. Approximately 60 eligible patients with hepatocellular carcinoma and portal vein tumor thrombus who have received three cycles of target-immunotherapy induction and have non-progressive disease will be enrolled. All patients must be considered unresectable or unable to tolerate surgical resection by MDT review and must provide written informed consent. Participants will be randomized 2:1. Forty patients will undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen; twenty patients will continue the original treatment regimen alone. OS, PFS, tumor response, QoL, safety, and postoperative outcomes will be observed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen
the original treatment regimen alone
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall Survival
Time from first antitumor treatment to death from any cause
Time frame: Up to 48 months
Progression-Free Survival
Time from randomization to first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first.
Time frame: Up to 48 months
Disease Control Rate
Proportion of participants achieving complete response, partial response, or stable disease per RECIST 1.1.
Time frame: Up to 48 months
Objective Response Rate
Proportion of participants achieving complete response or partial response per RECIST 1.1.
Time frame: Up to 48 months
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