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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT06361758
Eligibility Criteria:
Inclusion Criteria:
* Sign a written informed consent and be able to comply with the visit and related procedures required by the study protocol
* Age 18-75 years old, Male of Female
* ECOG PS 0-1
* histologically/cytologically or clinically (according to Chinese guidelines for primary liver cancer diagnosis and treatment (2022) criteria) confirmed initial diagnosis of HCC
* Not suitable for radical surgery and/or local treatment, BCLC stage C or stage B who failed local treatment
* Patients who progressed on first-line standard system therapy (Atezolizumab plus bevacizumab, sintilimab combined with bevacizumab, or Camrelizumab and Apatinib, only these three regimenes) or with intolerable toxicity ( except for immunotherapy intolerance)
* Child Pugh A-B7
* Expected survival timeā„12 weeks
* At least one measurable lesion (RECIST 1.1)
* Enough organ and bone marrow function
Exclusion Criteria:
* Fibrolamellar sarcomatoid or mixed cholangiocarcinoma-hepatocellular carcinoma.
* Other anti-tumor therapies have been received after first-line systemic anti-tumor therapy.
* Have history of hepatic encephalopathy, or a history of liver transplantation.
* There are clinical symptoms requiring drainage of pleural fluid, ascites, pericardial effusion.
* People with acute or chronic active hepatitis B or hepatitis C, hepatitis B virus (HBV) DNA \> 2000IU/ml or 10\^4 copies /ml; Hepatitis C virus (HCV) RNA \> 10\^3 copies /ml; Hepatitis B surface antigen (HbsAg) and anti-HCV antibodies were both positive.
* Central nervous system metastasis.
* Previous bleeding from esophageal or fundus varices due to portal hypertension occurred within 6 months.
* Autoimmune immune disease.
* HIV infection.
* Pregnant women.
* The presence of any serious or uncontrolled systemic disease.
* Other acute or chronic diseases, psychiatric disorders or abnormal laboratory test values that may lead to the following results: increasing the risk associated with research or drug administration, or interfering with the interpretation of research results. The Investigator considers that there are other potential risks that are not suitable for participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06361758
Study Brief:
Protocol Section:
NCT06361758