IRE
Conditions
Keywords
IRE
Brief summary
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.
Interventions
OTHERIRE
undergo open or percutaneous IRE followed by continuation of the original target-immunotherapy regimen
OTHERPLACEBO
the original treatment regimen alone
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * No prior palliative targeted immunotherapy or other systemic antitumor therapy * Maximum tumor diameter \<=5 cm and number of tumors \<=5 * No extrahepatic metastasis; portal vein tumor thrombus Vp1-3 * At least one measurable lesion according to RECIST 1.1 * Adequate organ and marrow function: hemoglobin \>=9.0 g/dL; neutrophils \>=1.5 x 10\^9/L; platelets \>=100 x 10\^9/L; TBIL \<=3 x ULN; AST and ALT \<=5.0 x ULN; serum creatinine \<=1.5 x ULN or CrCl \>60 mL/min by Cockcroft-Gault formula * ECOG Performance Status 0-1 * Expected survival of at least 3 months * Patients of childbearing potential and their partners agree to use contraception * Voluntary written informed consent
Exclusion criteria
* 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 * Major surgery within 30 days before screening * EGFR monoclonal antibody or EGFR-TKI within 30 days before screening * Allergy to any drug or component used in this protocol * Known or self-reported HIV infection or chronic hepatitis B or hepatitis C * Unresolved toxicity \>=CTCAE grade 2 from prior treatment, except anemia, alopecia, skin pigmentation, or chemotherapy-induced neurotoxicity * Any other reason judged by the investigator to make participation inappropriate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 48 months | Time from first antitumor treatment to death from any cause |
| Progression-Free Survival | Up to 48 months | Time from randomization to first documented disease progression per RECIST 1.1 or death from any cause, whichever occurs first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate | Up to 48 months | Proportion of participants achieving complete response, partial response, or stable disease per RECIST 1.1. |
| Objective Response Rate | Up to 48 months | Proportion of participants achieving complete response or partial response per RECIST 1.1. |
Countries
China
Outcome results
None listed