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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT04560894
Eligibility Criteria:
Inclusion Criteria:
* Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
* No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
* Child-Pugh ≤7 , no history of hepatic encephalopathy.
* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
* At least one measurable lesion based on Recist1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate hematologic and organ function.
Exclusion Criteria:
* Local treatment or surgery for liver lesions within 4 weeks.
* Prior liver or other organ transplantation.
* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
* Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
* Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
* Active known, or suspected autoimmune disease.
* Any condition that is not suitable for participate in this study as determined by investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04560894
Study Brief:
Protocol Section:
NCT04560894