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:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT07118735
Eligibility Criteria:
Inclusion Criteria:
* 1.Liver cancer patient who will receive immunotherapy
* 2.At least one measurable tumor, according to RECIST version 1.1, that has not been treated with any local procedure.
* 3.Age \>=20 years old.
* 4.ECOG performance status 0 or 1.
* 5.White blood count \>=2,000/microliter ; platelet count \>=60,000/microliter.
* 6.Liver transaminases (ALT and AST) \<=5 times upper limit of normal values (ULN); total bilirubin \<= 2 times ULN; creatinine clearance or eGFR \> 50 mL/min (either Cockcroft-Gault or MDRD is acceptable, whichever is higher).
* 7.Subjects with chronic hepatitis B virus infection (HBV surface antigen (HBsAg) positive) must start antiviral therapy with nucleoside analogs (e.g., entecavir or tenofovir, according to current practice guidelines) before start of study drug treatment.
Exclusion Criteria:
* 1.Major systemic diseases that the investigator considers inappropriate for participation.
* 2.Any active autoimmune disease or history of known autoimmune disease except for vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
* 3.Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
* 4.Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways).
* 5.Requirement of systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
* 6.Prior organ allograft or allogeneic bone marrow transplantation.
* 7.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07118735
Study Brief:
Protocol Section:
NCT07118735