TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Registration Number
- NCT04559607
- Lead Sponsor
- Zhongda Hospital
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of TACE in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced HCC.
- Detailed Description
This is a multicentric open-labal trial to evaluate the efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Apatinib versus TACE in patients with intermediate- and advanced hepatocellular carcinoma (HCC). The primary hypotheses is that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 188
-
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
- Participants who had another previous or current malignant tumor, except for early-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 marrow transplantation, or those who are in the waiting list for liver or bone marrow transplantation
- Participants who had congenital or acquired immune deficiency, such as HIV infection
- Participants who had a history of gastrointestinal bleeding within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding
- Participants who had undergone arterial thromboembolism within 6 months prior to randomization or a definite tendency of gastrointestinal bleeding, such as cerebrovascular accident, ≥ CTCAE grade 3 deep vein thrombosis and pulmonary embolism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group: TACE+Camrelizumab+Apatinib Camrelizumab Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE Experimental group: TACE+Camrelizumab+Apatinib TACE Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE Experimental group: TACE+Camrelizumab+Apatinib Apatinib Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE Control group: TACE TACE TACE
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) by investigator Up to ~2 years PFS is defined as the time from randomization to progression or death from any cause. Progression in this trial was determined as untreatable (UnTACEable) progression, defined as the inability of a patients to further receive or benefit from TACE for reasons. Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to ~4 years OS is defined as the time from randomization to death from any cause.
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) Up to ~2 years PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time to untreatable (unTACEable) progression (TTUP) by investigator Up to ~2 years TTUP is defined as the time from randomization to Child-Pugh grade C, intrahepatic tumor progression (\>50% increase vs baseline), MVI or EHS (diameter\>10 mm), and met the JSH criteria for TACE failure/refractoriness.
Trial Locations
- Locations (1)
Zhongda Hospital
🇨🇳Nanjing, Jiangsu, China