Last updated: December 10, 2023
Sponsor: Zhongda Hospital
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Liver Disorders
Liver Cancer
Abdominal Cancer
Treatment
Camrelizumab
Apatinib
TACE
Clinical Study ID
NCT04559607
MA-HCC-II-005
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology -≥18 years
- China liver cancer staging: Ib-IIIa
- Child-Pugh score ≤6 point
- Previous TACE treatment(≤2 times) is permitted
- Adequate organ and marrow function
Exclusion
Exclusion Criteria:
- Participants who had another previous or current malignant tumor, except forearly-stage cancer with low risk of recurrence or a malignant tumor curatively treated >5 years prior to enrolment with no recurrence
- Participants who have severe allergy to iodine, and unable to receive TACE
- Participants who have undergone a liver transplant or allogeneic bone marrowtransplantation, or those who are in the waiting list for liver or bone marrowtransplantation
- Participants who had congenital or acquired immune deficiency, such as HIV infection
- Participants who had a history of gastrointestinal bleeding within 6 months prior torandomization or a definite tendency of gastrointestinal bleeding
- Participants who had undergone arterial thromboembolism within 6 months prior torandomization or a definite tendency of gastrointestinal bleeding, such ascerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism
Study Design
Total Participants: 188
Treatment Group(s): 3
Primary Treatment: Camrelizumab
Phase:
Study Start date:
September 11, 2020
Estimated Completion Date:
January 31, 2026
Study Description
Connect with a study center
Zhongda Hospital
Nanjing, Jiangsu
ChinaSite Not Available

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