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 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
NCT ID:
NCT06524466
Eligibility Criteria:
Inclusion Criteria:
1. All patients must be pathologically confirmed to have hepatocellular carcinoma by biopsy；
2. No previous antitumor treatment;
3. Tumor number ≤ 3, diameter ≤ 10 cm, confined to one lobe of the liver or the middle lobe, evaluated by a surgeon as resectable;
4. Combined with vascular invasion, with the following extents: unilateral portal vein invasion without extending beyond the main portal vein; hepatic vein invasion not reaching the inferior vena cava; unilateral bile duct invasion not reaching the common hepatic duct;
5. No extra-hepatic metastasis or lymph node metastasis.
6. Normal liver volume ≥ 700 cc;
7. Patient KPS ≥ 90;
8. Liver function Child-Pugh class A;
9. Estimated survival of more than 6 months;
10. Function of important organs meets the following requirements: white blood cells ≥ 4.0×10\^9/l, neutrophils ≥ 1.5×10\^9/l, platelets ≥ 80.0×10\^9/l, hemoglobin ≥ 90 g/l; serum albumin ≥ 2.8 g/dl; total bilirubin ≤ 1.5× ULN, ALT/AST/ALP ≤ 2.5 × ULN; serum creatinine ≤ 1.5 × ULN or creatinine clearance rate \> 60 mL/min; no severe organic diseases;
11. The subject must be able to understand and voluntarily sign a written informed consent form, and must sign the informed consent form prior to any specific procedure of the study, agreeing to comply with the medication and postoperative follow-up requirements as designed in this study.
Exclusion Criteria:
1. Combined with severe impairment of functions of other important organs such as heart, lungs, and kidneys; active infections other than viral hepatitis or other serious comorbid conditions, making the patient unable to tolerate treatment;
2. Diffuse type of HCC, or tumor volume exceeding 50% of liver volume;
3. Portal vein invasion extending beyond the main tract of the portal vein, or hepatic vein invasion reaching the inferior vena cava, or bile duct invasion extending beyond the common hepatic duct;
4. Contraindications to surgical resection, SBRT and immunotherapy;
5. History of other malignant tumors;
6. Combined with immunological diseases or other conditions requiring long-term steroid treatment;
7. Known or suspected allergy to the study drug or any drugs administered in connection with this trial;
8. History of organ transplantation;
9. Pregnant or breastfeeding women;
10. Other factors that may affect patient enrollment and assessment outcomes;
11. Refusal to follow-up according to the requirements set by the study protocol, and refusal to sign the informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06524466
Study Brief:
Protocol Section:
NCT06524466