Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06193733
Eligibility Criteria:
Inclusion Criteria:
* The patients have curative liver resection for primary or recurrent HCCs which are diagnosed by pathological figures, and the risk nomogram scores of tumor recurrence are ≥ 101 \[Hepatitis, score 57; platelet \< 100x103 , score72 ; multiple tumors, score 69 ; cirrhosis, score 62 ; microvascular invasion, score 100 ; total tumor volume \> 43.3cm3 ,score 90\]
* Age ≧20 years old and sign informed consent.
* BCLC stage A-C
* Child-Pugh sore ≤ 6
* Percentage of lymphocytes in peripheral blood ≧12%.
* Performance status ECOG ≦2
* AST and ALT ≦ 5x upper limit of normal.
* Platelet ≥ 80000/mm3
* WBC ≥ 3000/uL
* RBC ≥ 2.5x106/uL
* eGFR ≥ 30ml/min/1.73m2
* The patients must be disease-free after liver resection, which is confirmed by dynamic CT or MRI within 14 days.
* The participates must have early stage or intermediate stage of HCC and receive liver resections to remove the tumors completely.
* The participates must agree to harvest and preserve tumor specimens during operation.
Exclusion Criteria:
* Subjected having other malignancy except HCC are excluded.
* Uncontrolled or clinical significant cardiac diseases.
* Positive for HIV.
* Active bacterial of fungal infections.
* Prior chemotherapy within one month.
* Use of other investigational drug within one month.
* Subjects with systemic steroid treatment within 14 days.
* Subjects in the status of immune deficiency.
* Subjects in the status of autoimmune diseases.
* Subjects with Long-term use of immunosuppressive agents.
* Subjects with checkpoint inhibitor immunotherapy within one month.
* Subjects with local reginal therapy within one month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT06193733
Study Brief:
Protocol Section:
NCT06193733