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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT07014150
Eligibility Criteria:
Inclusion Criteria:
* The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up
* Be at least 18 years old at the time of signing the informed consent form, with no gender restrictions.
* Hepatocellular carcinoma diagnosed by histology or imaging
* At least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm)
* No systematic treatment has been received before
* CNLC：Ib to IIIa
* There is at least one of the following high-risk factors for postoperative recurrence: AFP\>400ng/ml; Single tumor \>5cm; The number of tumors is greater than 3 or any one of them is greater than 3cm; There are vascular tumor thrombus or tumors adjacent to large blood vessels, etc.
* The ECOG score was 0-1 within one week before enrollment
* Hematology and organ functions are adequate
* Fertile women: Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during the treatment period and for at least 6 months after the last administration
Exclusion Criteria:
* Have received any systemic treatment
* ECOG score \>1
* Definite extrahepatic metastasis
* Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
* Those who are known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components (or any excipients)
* Previous or existing grade 3 or above digestive tract fistulas or non-digestive tract fistulas (such as skin) as defined by CTCAE 5.0 criteria
* Major surgical operations (except biopsy) have been performed within 4 weeks before the first study of drug treatment or the surgical incision has not fully healed
* Cardiovascular and cerebrovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction and severe/unstable angina pectoris that occurred within 6 months before enrollment
* Insufficiency of liver and kidney functions, such as jaundice, ascites, and/or bilirubin \>3×ULN, creatinine ratio \>3.5g/24 hours, etc
* Persistent infection of grade \>2 (CTCAE 5.0)
* A history of thromboembolism (including stroke and/or transient ischemic attack) within the past 6 months
* Hypertension that has not been well controlled after antihypertensive drug treatment (systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg)
* An active autoimmune disease or a history of autoimmune diseases in the past two years
* Active central nervous system (CNS) metastases and/or cancerous meningitis
* Be ready or have received organ or allogeneic bone marrow transplants before
* Known history of active tuberculosis (Mycobacterium tuberculosis)
* A history of gastrointestinal bleeding within the past 6 months or a clear tendency towards gastrointestinal bleeding
* History of human immunodeficiency virus (HIV) infection
* Positive for active hepatitis B or hepatitis C and has not received regular treatment. During the screening period, HBV DNA≥2000 IU/ml (or ≥104 copy number /ml), entecavir must be used to reduce it to \<2000 IU/ml (or \< 104 copy number /ml) before enrollment
* There is drug abuse; Or any medical, psychological or social conditions that may affect the research, cause unstable patient compliance, or even endanger patient safety
* Unresolved toxicity of grade \> 1 due to any previous treatment/procedure (CTCAE 5.0, excluding alopecia, anemia, and hypothyroidism).
* Patients with objective evidence of severe lung function impairment in the past or at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, and drug-related pneumonia
* Received treatment with potent CYP3A4 inhibitors within 7 days before participating in the study
* Accompanied by other malignant tumors, but having had other untreated malignant tumors in the past (within 5 years) or simultaneously, for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the breast and carcinoma in situ of the cervix, treated superficial bladder cancer and prostate adenocarcinoma that has undergone surgical treatment and whose PSA tumor markers are within the normal range.
* After a comprehensive assessment of the patient's condition by the researchers, it was determined that they were not suitable to participate in this research
* Participate in another clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07014150
Study Brief:
Protocol Section:
NCT07014150