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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT05831969
Eligibility Criteria:
Inclusion Criteria:
1. Willing and able to sign a written informed consent;
2. Age ≥ 18 and ≤ 75 years old on the day of signing the informed consent form;
3. Locally advanced hepatocellular carcinoma, clinical diagnosis of hepatocellular carcinoma by histology/cytology, imaging (enhanced MRI or enhanced CT or PET-CT);
4. Advanced metastatic and/or unresectable HCC progresses after combination therapy with lenvatinib combined with PD-1 inhibitors (must be domestically approved for use in liver cancer);
5. Eastern Cooperative Oncology Group (ECOG) physical status score is 0 or 1;
6. Liver function in line with Child-Pugh A grade (score 5-6 points);
7. Hepatitis B surface antigen detection is required before enrollment. For patients who are confirmed to have hepatitis B, antiviral drugs should be started 1 week before treatment;
8. During the study screening period, patients must be tested for hepatitis C virus (HCV) RNA status. This study allowed for the study of patients with untreated chronic HCV infection. In addition, patients who have been cured of hepatitis C can be included in this study, but the hepatitis C treatment should be completed for more than 4 weeks at the time of enrollment;
9. The main organ functions are basically normal and meet the following requirements:
Bone marrow: absolute neutrophil count ≥1.5×109/L, platelet ≥50×109/L, hemoglobin ≥90g/L.
Liver: total bilirubin ≤ 2 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 5 × ULN, albumin ≥ 29 g/L.
Kidney: serum creatinine ≤1.5×ULN, or creatinine clearance ≥50mL/min. Coagulation function: international normalized ratio (INR) ≤ 2, and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
10. The expected survival time is more than 3 months;
11. Patients with other malignant tumors have lived disease-free for more than 2 years after initial treatment (such as non-melanoma skin cancer or cervical cancer in situ);
12. Women of childbearing age must agree to use effective contraception for at least 4 weeks before enrollment in the study, during the study and within 4 weeks after the withdrawal of the study drug. Women of childbearing potential require a serum pregnancy test within 72 hours of starting treatment. Male subjects must also use effective contraception during treatment and within 4 weeks of drug withdrawal. The spouse of the subject also needs to do a good job of contraception during the subject's participation in the study;
13. Did not participate in other clinical trials within 4 weeks before screening; those who failed to screen in other trials but met the requirements of this trial can be enrolled.
Exclusion Criteria:
1. Hypersensitivity to iridamine drugs;
2. Fibrolamellar or sarcomatoid HCC;
3. Mixed HCC-ICC;
4. Currently participating in and receiving other experimental treatments, or participating in a study of immune checkpoint inhibitors and receiving study treatment;
5. Previous solid organ transplantation, diagnosed as immunodeficiency, or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before the first trial treatment;
6. Esophageal or gastric variceal bleeding within 3 months before enrollment;
7. Hepatic encephalopathy in the past 6 months, or obvious ascites at the time of enrollment;
8. Have a known history of active tuberculosis;
9. Hypersensitivity to PD-1 inhibitors;
10. The subject has other known aggressive malignant tumors at the same time (except for those who have no evidence of tumor recurrence after treatment and the duration is more than 2 years). Exceptions include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, low-risk prostate cancer, or cervical cancer in situ;
11. Patients with previous active autoimmune diseases requiring systemic treatment;
12. History or any evidence of known active non-infectious pneumonia;
13. Active infection requires systemic treatment;
14. People with known mental illness or substance abuse disorder;
15. Pregnant or lactating women;
16. Known human immunodeficiency virus (HIV) medical history (HIV 1/2 antibody);
17. Have been vaccinated with live vaccines within 30 days before starting the study treatment;
18. Those who suffer from high blood pressure and cannot be well controlled by antihypertensive drug treatment (systolic blood pressure\>140mmHg, diastolic blood pressure\>100mmHg); suffer from myocardial ischemia or myocardial infarction above CTCAE grade II, poorly controlled arrhythmia, And/or New York Heart Association (NYHA) class III\~IV cardiac insufficiency;
19. Other conditions that the investigator believes prevent patients from participating in this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05831969
Study Brief:
Protocol Section:
NCT05831969