Back to resultsTACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Camrelizumab
TACE
Apatinib
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of HCC confirmed by radiology, histology, or cytology
-≥18 years
- China liver cancer staging: IIb-IIIa
- Child-Pugh score ≤6 point
- 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
- 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
Sites / Locations
- Zhongda HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group: TACE+Camrelizumab+Apatinib
Control group: TACE
Arm Description
Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE
TACE
Outcomes
Primary Outcome Measures
Progression-free survival (PFS) by investigator
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)
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)
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
PFS by independent review committee according to mRECSIT
PFS by independent review committee according to mRECSIT
Time to untreatable (unTACEable) progression (TTUP) by investigator
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04559607
Brief Title
TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
Official Title
TACE Combined With Camrelizumab and Apatinib Versus TACE in Intermediate and Advanced Hepatocelluar Carcinoma: a Randomized, Open-label, Multi-center Clinical Trials
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongda Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group: TACE+Camrelizumab+Apatinib
Arm Type
Experimental
Arm Description
Camrelizumab (iv. infusion of 200 mg); Apatinib (po. administration of 250 mg); TACE
Arm Title
Control group: TACE
Arm Type
Active Comparator
Arm Description
TACE
Intervention Type
Drug
Intervention Name(s)
Camrelizumab
Intervention Description
Camrelizumab: 200mg, iv, Q3W
Intervention Type
Device
Intervention Name(s)
TACE
Intervention Description
TACE if necessary
Intervention Type
Drug
Intervention Name(s)
Apatinib
Intervention Description
Apatinib: 250m, po, QD
Primary Outcome Measure Information:
Title
Progression-free survival (PFS) by investigator
Description
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.
Time Frame
Up to ~2 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization to death from any cause.
Time Frame
Up to ~4 years
Title
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Description
PFS by investigator according to modified Response Evaluation Criteria in Solid Tumors (mRECIST)
Time Frame
Up to ~2 years
Title
PFS by independent review committee according to mRECSIT
Description
PFS by independent review committee according to mRECSIT
Time Frame
Up to ~2 years
Title
Time to untreatable (unTACEable) progression (TTUP) by investigator
Description
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)
Time Frame
Up to ~2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of HCC confirmed by radiology, histology, or cytology
-≥18 years
China liver cancer staging: IIb-IIIa
Child-Pugh score ≤6 point
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hai-Dong Zhu, Doctor
Phone
13851420979
Email
zhuhaidong9509@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gao-Jun Teng, Doctor
Organizational Affiliation
Zhongda Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongda Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Zhu, Doctor
Phone
13851420979
Email
zhuhaidong9509@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TACE Combined With Camrelizumab and Apatinib in Intermediate and Advanced Hepatocelluar Carcinoma
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