TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 are that TACE in combination with Camrelizumab and Apatinib is superior to TACE alone with respect to progression-free survival (PFS).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Experimental group: TACE+Camrelizumab+Apatinib Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE |
Drug: Camrelizumab
Camrelizumab: 200mg, iv, Q3W
Device: TACE
TACE if necessary
Drug: Apatinib
Apatinib: 250m, po, QD
|
Active Comparator: Control group: TACE TACE |
Device: TACE
TACE if necessary
|
Outcome Measures
Primary Outcome Measures
- 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 that included intrahepatic tumor progression (50% increased vs baseline) according to Response Evaluation Criteria in Cancer of the Liver (RECICL) version 5, transient deterioration of liver function to Child-Pugh C right after TACE, macrovascular invasion (MVI) or extra hepatic spread (EHS) (diameter>10 mm). Progression in this trial also included progression that met the JSH criteria for TACE failure/refractoriness.
Secondary Outcome Measures
- 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)
- PFS by independent review committee according to mRECSIT [Up to ~2 years]
PFS by independent review committee according to mRECSIT
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Has a diagnosis of HCC confirmed by radiology, histology, or cytology
-≥18 years
-
China liver cancer staging: IIb-IIIa
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Child-Pugh score ≤6 point
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No prior systemic anticancer therapy for HCC
-
Adequate organ and marrow function
Exclusion Criteria:
- 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
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Participants who had congenital or acquired immune deficiency, such as HIV infection
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Zhongda Hospital | Nanjing | Jiangsu | China |
Sponsors and Collaborators
- Zhongda Hospital
Investigators
- Principal Investigator: Gao-Jun Teng, Doctor, Zhongda Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MA-HCC-II-005