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 @ 1:08 AM
Ignite Modification Date:
2025-12-25 @ 1:08 AM
NCT ID:
NCT03764293
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically or cytologically confirmed advanced HCC
* No previous systematic treatment for HCC
* Have at least one measurable lesion (in accordance with RECIST v1.1)
* BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
* ECOG-PS score 0 or 1
* Child-Pugh Class: Grade A
* Life Expectancy of at least 12 weeks
* Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study
* Subjects with HCV-RNA(+) must receive antiviral therapy
* Adequate organ function
Exclusion Criteria:
* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
* Moderate-to-severe ascites with clinical symptoms
* History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Known genetic or acquired hemorrhage or thrombotic tendency
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Cardiac clinical symptom or disease that is not well controlled
* Hypertension that can not be well controlled through antihypertensive drugs
* Factors to affect oral administration
* History of hepatic encephalopathy
* Previous or current presence of metastasis to central nervous system
* HIV infection
* Combined hepatitis B and hepatitis C co-infection
* Be ready for or previously received organ or allogenic bone marrow transplantation
* Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
* Active known, or suspected autoimmune disease
* Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment
* Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Severe infection within 4 weeks prior to the start of study treatment
* Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment
* Treatment of other investigational product(s) within 28 days prior to the start of study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03764293
Study Brief:
Protocol Section:
NCT03764293