Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients
Exploratory Clinical Study of TACE Combined With Camrelizumab in the Treatment of BCLC Stage B and Stage C Hepatocellular Carcinoma
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Shanghai
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Shanghai, Shanghai, China, 200032
- Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1.Patients voluntarily entered the study and signed informed consent form (ICF) 2. Age: 18 - 80 years old and life expectancy of at least 12 weeks.; 3. Clinically or histologically diagnosed as HCC; 4. There are measurable lesions that meet the RECIST1.1 standard on the baseline imaging examination; 5. Child-pugh classification A or B (score < 7); 6. The BCLC stage is stage B or C, and it is unable or unwilling to undergo surgical treatment; 7. ECOG : 0 ~ 1 ; 8. No previous immune checkpoint inhibitor treatment (including PD-1 / PD-L1 antibody and CTLA-4 inhibitor); 9. HBV-deoxyribonucleic acid (DNA) must be <500IU / mL, and receive at least 14 days of anti-HBV treatment before the start of study treatment Treatment;
Exclusion Criteria:
- 1. History of treatment with any local treatment (exception of liver transplantation), systemic .anti-cancer therapy, or immunotherapy; 2. Those whose tumor thrombus reaches or exceeds the main portal vein; 3. Existing or concurrently suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma; 4. There is any active autoimmune disease or has a history of autoimmune disease and may relapse; 5. Use strong CYP3A4 / CYP2C19 inducers including rifampicin and Hypericum perforatum or strong CYP3A4 / CYP2C19 inhibitors within 14 days before starting the study treatment; 6. Known history of severe allergy to any monoclonal antibody; 7. Patients who are going to undergo or have undergone organ or allogeneic bone marrow transplantation; 8. Non-compliance with TACE or Camrelizumab; 9. Moderate and severe ascites with clinical symptoms require therapeutic puncture, drainage, or Childa-Pugh score> 2 (except imaging only shows a small amount of ascites but not accompanied by clinical symptoms); uncontrolled or moderate and Above pleural effusion and pericardial effusion; 10. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before the start of the study treatment; 11. Thrombosis or embolism occurred within 6 months before the start of study treatment, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction, pulmonary embolism, etc.) 12. Known inherited or acquired bleeding or thrombophilia ; currently or recently (10 days prior to the start of study treatment) have used full dose oral or Injection of anticoagulant drugs or thrombolytic drugs (prophylactic use of low-dose aspirin and low molecular weight heparin); 13. Major vascular disease within 6 months before the study treatment; 22. Past or present central nervous system metastasis; 14. Metastatic diseases involving major airways or blood vessels or a large mediastinal tumor mass in the center (<30 mm from the crest) 15. Those with a history of hepatic encephalopathy; 16. Palliative radiotherapy for non-target lesions allowed for symptom control must be completed at least 2 weeks before the start of study treatment. Adverse events caused by radiotherapy have not recovered to ≤CTCAE level 1; 17. There were severe infections within 4 weeks before starting the study treatment; 18. Patients with congenital or acquired immune deficiency (such as those infected with HIV); 19. Co-infection with hepatitis B and C; 20. For patients with bone metastases, the palliative radiotherapy area> 5% bone marrow area received within 4 weeks before participating in the study;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: TACE combined with Camrelizumab
Camrelizumab(200mg q3w ivgtt)combined with TACE,the interval between TACE treatment and Carilizumab is not less than 7 days.
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Camrelizumab(200mg q3w ivgtt) combined with TACE
Other Names:
Camrelizumab(200mg q3w ivgtt) combined with TACE
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression Free Survival
Time Frame: an expected average of 8 months
|
the time from enrollment to the first disease progression or death from any cause
|
an expected average of 8 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to progression
Time Frame: An expected average of 8 months
|
the time from enrollment to the first disease progression
|
An expected average of 8 months
|
|
Overall survival
Time Frame: An expected average of 24 months
|
the time from enrollment to the death from any cause
|
An expected average of 24 months
|
|
Objective response rate
Time Frame: An expected average of 8 months
|
evaluated by investigators with mRECIST
|
An expected average of 8 months
|
|
Disease control rate
Time Frame: An expected average of 8 months
|
evaluated by investigators with mRECIST
|
An expected average of 8 months
|
|
Duration of response
Time Frame: An expected average of 8 months
|
evaluated by investigators with mRECIST
|
An expected average of 8 months
|
|
The incidence of AEs and SAEs by NCI-CTCAE v5.0
Time Frame: An expected average of 8 months
|
Safety index
|
An expected average of 8 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Yan zhiping, M.D., Shanghai Zhongshan Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens, Non-Steroidal
- Estrogens
- Chlorotrianisene
Other Study ID Numbers
Other Study ID Numbers
- MA-HCC-Ⅱ-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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