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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT04444167
Eligibility Criteria:
Inclusion Criteria:
* Signed written informed consent form voluntarily.
* Histologically or cytologically documented hepatocellular carcinoma.
* BCLC stage C, and non-resectable BCLC stage B .
* At least one measurable lesion according to RECIST criteria.
* ECOG of 0 or 1.
* Adequate organ function.
* Estimated life expectancy of ≥3 months.
* For women of childbearing potential: agreement to remain abstinent; For men: agreement to remain abstinent.
Exclusion Criteria:
* Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
* History of hepatic encephalopathy or liver transplantation.
* Clinical significance of hydrothorax, ascites or pericardial effusion.
* Central nervous system metastases and/or carcinomatous meningitis.
* Any risk of bleeding; severe bleeding tendency or coagulation dysfunction, or under thrombolytic therapy.
* Occurred arteriovenous thromboembolic events within 6 months before the first administration.
* Tumor volume \> 50% liver volume; portal vein tumor thrombus or inferior vena cava tumor thrombus.
* Inadequately controlled arterial hypertension.
* Attack of symptomatic congestive heart failure (LVEF\<50%); History of congenital long QT syndrome.
* Known presence or history of interstitial lung disease or required hormone treatment interstitial lung disease.
* Severe infections.
* Receipt of any anti-tumor treatment, chemotherapy, targeted therapy, immunotherapy,
* Enrollment of another clinical study within 4 weeks prior to the first administration of study drugs.
* Unable to receive an enhanced CT or MRI scan of the liver.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04444167
Study Brief:
Protocol Section:
NCT04444167