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

It is an exploratory clinical study aimed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C HCC.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: TACE combined with Camrelizumab; Procedure: TACE plus Camrelizumab

Detailed Description

This is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of TACE combined with Camrelizumab in the treatment of patients with BCLC stage B and C hepatocellular carcinoma.Treatment will continue until disease progression or intolerable toxicity or patients withdrawal of consent,and the target sample size is 60 individuals.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Department of Interventional Radiology, Zhongshan Hospital, Fudan University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

1

Arms and Interventions

Participant Group / Arm	Intervention / 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.	Drug: TACE combined with Camrelizumab; Camrelizumab(200mg q3w ivgtt) combined with TACE; Other Names: TACE plus Camrelizumab; Procedure: TACE plus Camrelizumab; Camrelizumab(200mg q3w ivgtt) combined with TACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	the time from enrollment to the first disease progression or death from any cause	an expected average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to progression	the time from enrollment to the first disease progression	An expected average of 8 months
Overall survival	the time from enrollment to the death from any cause	An expected average of 24 months
Objective response rate	evaluated by investigators with mRECIST	An expected average of 8 months
Disease control rate	evaluated by investigators with mRECIST	An expected average of 8 months
Duration of response	evaluated by investigators with mRECIST	An expected average of 8 months
The incidence of AEs and SAEs by NCI-CTCAE v5.0	Safety index	An expected average of 8 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Yan zhiping, M.D., Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

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: MA-HCC-Ⅱ-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No