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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT04152356
Eligibility Criteria:
Inclusion Criteria:
* Pathological diagnosis of primary hepatocellular carcinoma, BCLC stage A, liver function Chid-Pugh grade A, or liver function Child-Pugh classification changed from grade B to grade A after short-term liver treatment, PS score 0- 1 point. Received surgical treatment of primary hepatocellular carcinoma (RO resection).
* Complete resection of postoperative macroscopic and imaging, no residual cancer;
* No large blood vessels (2-pole branches) and bile duct invasion, no macroscopic tumor thrombus;
* Negative margin: the margin of the liver is \>1 cm from the tumor boundary; if the margin is \<1 cm, but the histological examination of the resected liver section showed no residual tumor cells, that is, the margin was negative;
* AFP negative: \<20 ug/L;
* No lymph node invasion, no distant metastasis;
* Laboratory inspection inclusion criteria:
* Neutrophils ≥ 1.5 × 109 / L;
* Platelets ≥ 50 × 109 / L;
* Hemoglobin ≥ 90 g / L;
* Serum creatinine ≤ 1.5 × upper limit of normal (ULN) and creatinine clearance ≥ 50 mL/min;
* AST, ALT ≤ 2.5 × ULN;
* Serum bilirubin ≤ 1.25 × ULN;
* Patients who did not receive anticoagulant therapy: INR or aPTT ≤ 1.5 × ULN. If the patient received prophylactic anticoagulant therapy, the INR ≤ 2 × ULN within 14 days before the study treatment and the aPTT was within the normal range, the patients were acceptable for enrollment.
* With one of the following high risk factors:
* Single lesion \>5cm;
* Single lesion, 3-5cm, with MVI M1/M2;
* Single lesion, \<3cm, MVI M2;
* Multiple lesions (2-3)
* General inclusion criteria:
* Age 18-75;
* No anti-tumor treatment history before surgery;
* Agree to provide tissue and pathological specimens;
* ECOG 0 points;
* For women of gestational age, no pregnancy plan and continued full contraception.
Exclusion Criteria:
* Pathological diagnosis of primary hepatocellular carcinoma, BCLC stage B, C, D, liver function Child-Pugh grade C, PS score of 2 points and above. Biliary cells or mixed cell carcinoma confirmed by postoperative pathology. No surgery was performed.
* Preoperative treatment of TACE or radiotherapy and chemotherapy, and targeted anti-tumor therapy.
* One month after the operation, the rest of the anti-tumor treatment was performed, or combined with two or more anti-tumor pain treatment.
* There were lymph nodes and distant metastases before surgery.
* Have a history of active autoimmune disease or autoimmune disease;
* Inoculated with any anti-infective vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before randomization;
* Use immunosuppressive agents, or systemic, or absorbable local hormones to achieve immunosuppressive purposes (dose \> 10 mg/day of prednisone or other equivalent hormones) and continue to be used within 2 weeks prior to randomization;
* Any significant clinical and laboratory abnormalities;
* Researchers believed that the patient effected safety evaluation, such as: uncontrollable active infections, uncontrolled diabetes, high blood pressure could not be reduced to the following range by monotherapy (systolic blood pressure \< 140 mmHg, diastolic blood pressure \< 90 mmHg), peripheral neuropathy grade II or above, congestive heart failure, myocardial infarction within 6 months, chronic kidney disease;
* Main or main branch tumor thrombus (preoperative imaging or intraoperative findings) or extrahepatic disseminated or recurrent liver cancer.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04152356
Study Brief:
Protocol Section:
NCT04152356