Hepatocellular Carcinoma
Conditions
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).
Interventions
DRUGCamrelizumab
Camrelizumab: 200mg, iv, Q3W
DEVICETACE
TACE if necessary
DRUGApatinib
Apatinib: 250m, po, QD
Sponsors
Zhongda Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed