IRE After Targeted Immunotherapy in HCC With Portal Vein Tumor Thrombus
ConditionIRE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTianjin Medical University Cancer Institute and Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years, any sex
Imaging-confirmed or histologically confirmed primary liver cancer/hepatocellular carcinoma (HCC)
After three cycles of target-immunotherapy induction, MDT review determines unresectable disease or inability to tolerate surgical resection
Willingness to receive standard conversion treatment
Disqualifiers
Refusal to receive systemic therapy or possible surgery
Metastasis to other sites, such as lymph nodes, peritoneum, lung, bone, or brain
History of other malignancies, except cured basal cell carcinoma of the skin or cervical carcinoma in situ
Severe uncontrolled comorbidities, including uncontrolled congestive heart failure (NYHA III/IV), unstable angina, poorly controlled arrhythmia, uncontrolled hypertension, active infection, uncontrolled diabetes, uncontrolled pleural effusion/pericardial effusion/ascites requiring drainage, severe portal hypertension or portal cavernoma on imaging, gastric outlet obstruction, or respiratory insufficiency requiring oxygen
Trial design
Design model
Parallel
Treatments tested in this trial
IRE
Other interventionundergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen
PLACEBO
Other interventionthe original treatment regimen alone
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: IRE + chemotherapy continuationExperimental treatment 1 intervention
Group B: chemotherapy continuation alonePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival
Time from first antitumor treatment to death from any cause
Time frame
Up to 48 months2
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 monthsSecondary outcomes
1
Disease Control Rate
Proportion of participants achieving complete response, partial response, or stable disease per RECIST 1.1.
Time frame
Up to 48 months2
Objective Response Rate
Proportion of participants achieving complete response or partial response per RECIST 1.1.
Time frame
Up to 48 monthsSponsors and contacts
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Source ClinicalTrials.gov