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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT05609695
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent must be obtained prior to any screening procedures.
2. Cytohistological confirmation is required for diagnosis of HCC.
3. Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
4. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.
5. Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
6. Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
7. astern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
8. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
9. Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
Hemoglobin \> 100g/L Absolute neutrophil count \>3.0 ×109/L Neutrophil count \> 1.5 ×109/L Platelet count ≥ 50.0 ×109/L Total bilirubin \< 51 μmol/L Alanine transaminase (ALT) and aminotransferase (AST) \< 5 x upper limit of normal Albumin \> 28 g/L Prothrombin time (PT)-international normalized ratio (INR) \< 2.3, or PT \< 6 seconds above control Serum creatinine \< 110 μmol/L
10. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
Exclusion Criteria:
1. Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
2. Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade 1.
3. Any contraindications for Immune checkpoint inhibitor procedure
4. Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
5. Known severe atheromatosis.
6. Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
7. Patients with any other malignancies within the last 3 years before study start.
8. History of HCC tumor rupture.
9. Patients with severe encephalopathy. Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
10. History of cardiac disease.
11. Any other condition that would, in the Investigator's judgment, contraindicate patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., infection/inflammation, intestinal obstruction, unable or unwilling to swallow medication, social/ psychological issues, etc.
12. Patients who have received any other investigational agents within a period of time that is less than the cycle length used for that treatment or equal to 4 weeks (whichever is shorter) prior to starting study drug and recovered from any side effects to grade 1 or less.
13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05609695
Study Brief:
Protocol Section:
NCT05609695