Back to resultsA Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
TACE+Camrelizumab+Apatinib mesylate
TACE
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Voluntarily participate in this study and sign informed consent.
- Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
- Baseline imaging examination has at least one measurable lesion.
- Child-Pugh liver function rating was Grade A Within 7 days before randomization.
- ECOG PS score within 7 days before randomization: 0 or 1. Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
- Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
- Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
- Has any active autoimmune disease or a history of autoimmune disease and may relapse.
- Suffering from hypertension and can not be well controlled by antihypertensive drugs.
- With clinical symptoms or diseases of the heart that are not well controlled.
- Previous or current central nervous system metastasis.
- The subject has congenital or acquired immune deficiency (such as HIV infection).
- Thrombotic or embolic events occurred within 6 months prior to the start of study treatment.
- A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment.
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.
- Severe, unhealed or cracked wounds and active ulcers or untreated fractures.
- Known genetic or acquired bleeding or thrombotic tendencies.
- Severe infection occurred within 4 weeks prior to the start of study treatment.
- Received live attenuated vaccine treatment within 28 days prior to the start of study treatment.
- Other investigational drugs were received within 28 days prior to the start of study treatment.
- According to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. Other protocol defined exclusion criteria could apply.
Sites / Locations
- Zhongshan Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment group
Control group
Arm Description
TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).
TACE Alone.
Outcomes
Primary Outcome Measures
PFS assessed by BIRC
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
Secondary Outcome Measures
OS
OS is defined as the time from the date of randomization until death due to any cause.
ORR
ORR is defined as the percentage of participants in the analysis population who have a CR or PR.
DCR
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.
DoR
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Full Information
NCT ID
NCT05320692
First Posted
April 2, 2022
Last Updated
October 17, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05320692
Brief Title
A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma
Official Title
A Phase III, Randomized, Open-Label, Multi-center Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) or TACE Alone in Patients With Incurable Hepatocellular Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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
A study to evaluate efficacy and safety of transarterial chemoembolization (TACE) in combination with Camrelizumab and Rivoceranib (Apatinib) therapy in patients with incurable hepatocellular carcinoma.
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
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a Randomized, Open-Label, Multi-center phase III clinical trial。
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
TACE Alone.
Intervention Type
Drug
Intervention Name(s)
TACE+Camrelizumab+Apatinib mesylate
Intervention Description
TACE. Camrelizumab，200mg，iv，once every 3 weeks. Apatinib mesylate, 250 mg, administered orally once daily，once every 3 weeks.
Intervention Type
Procedure
Intervention Name(s)
TACE
Intervention Description
TACE Alone.
Primary Outcome Measure Information:
Title
PFS assessed by BIRC
Description
PFS is defined as the time from the date of randomization until the date of first objective disease progression or death (whichever occurs first).
Time Frame
approximately 5 years
Secondary Outcome Measure Information:
Title
OS
Description
OS is defined as the time from the date of randomization until death due to any cause.
Time Frame
approximately 5 years
Title
ORR
Description
ORR is defined as the percentage of participants in the analysis population who have a CR or PR.
Time Frame
approximately 5 years
Title
DCR
Description
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD.
Time Frame
approximately 5 years
Title
DoR
Description
DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first.
Time Frame
approximately 5 years
Title
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) as assessed by CTCAE v5.0
Time Frame
approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Voluntarily participate in this study and sign informed consent.
Subjects diagnosed with HCC or clinically diagnosed with HCC by histopathology / cytology.
Baseline imaging examination has at least one measurable lesion.
Child-Pugh liver function rating was Grade A Within 7 days before randomization.
ECOG PS score within 7 days before randomization: 0 or 1. Other protocol defined inclusion criteria could apply.
Exclusion Criteria:
Known hepatocholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed cell carcinoma and lamellar cell carcinoma.
Subjects who are ready for or have previously received organ or allogeneic bone marrow transplantation.
Has any active autoimmune disease or a history of autoimmune disease and may relapse.
Suffering from hypertension and can not be well controlled by antihypertensive drugs.
With clinical symptoms or diseases of the heart that are not well controlled.
Previous or current central nervous system metastasis.
The subject has congenital or acquired immune deficiency (such as HIV infection).
Thrombotic or embolic events occurred within 6 months prior to the start of study treatment.
A history of gastrointestinal hemorrhage or a clear tendency to gastrointestinal bleeding within 6 months prior to the start of study treatment.
Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months prior to the start of study treatment.
Severe, unhealed or cracked wounds and active ulcers or untreated fractures.
Known genetic or acquired bleeding or thrombotic tendencies.
Severe infection occurred within 4 weeks prior to the start of study treatment.
Received live attenuated vaccine treatment within 28 days prior to the start of study treatment.
Other investigational drugs were received within 28 days prior to the start of study treatment.
According to the assessment of investigator, the subject has other factors that may interfere with the results of the study or cause the forced termination of the study. Other protocol defined exclusion criteria could apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linna Wang
Phone
+0518-81220121
Email
linna.wang@hengrui.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hejuan Song
Phone
+0518-81220121
Email
hejuan.song@hengrui.com
Facility Information:
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jia Fan
Phone
021-64041990
Email
fan.jia@zs-hospital.sh.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Study of TACE Combined With Camrelizumab Plus Rivoceranib (Apatinib) in Patients With Incurable Hepatocellular Carcinoma
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