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Active, not recruitingNCT04483284Updated Aug 1, 2024

Study of TACE Combined With Camrelizumab in the Treatment of HCC Patients

A Phase 2 interventional study of TACE combined with Camrelizumab and TACE plus Camrelizumab in Hepatocellular Carcinoma, sponsored by Shanghai Zhongshan Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-01.

Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 28 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • 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 · Procedure: TACE plus Camrelizumab

Interventions

  • DrugTACE combined with Camrelizumab

    Camrelizumab(200mg q3w ivgtt) combined with TACE

    Also known as: TACE plus Camrelizumab

  • ProcedureTACE plus Camrelizumab

    Camrelizumab(200mg q3w ivgtt) combined with TACE

06

What researchers measure

Primary outcomes

  1. Progression Free Survival

    the time from enrollment to the first disease progression or death from any cause

    Time frame: an expected average of 8 months

Secondary outcomes

  1. Time to progression

    the time from enrollment to the first disease progression

    Time frame: An expected average of 8 months

  2. Overall survival

    the time from enrollment to the death from any cause

    Time frame: An expected average of 24 months

  3. Objective response rate

    evaluated by investigators with mRECIST

    Time frame: An expected average of 8 months

  4. Disease control rate

    evaluated by investigators with mRECIST

    Time frame: An expected average of 8 months

  5. Duration of response

    evaluated by investigators with mRECIST

    Time frame: An expected average of 8 months

  6. The incidence of AEs and SAEs by NCI-CTCAE v5.0

    Safety index

    Time frame: An expected average of 8 months

07

Study locations

1 site
  • Department of Interventional Radiology, Zhongshan Hospital, Fudan University.
    Shanghai, Shanghai 200032, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04483284
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Jul 23, 2020
Start date
Jun 24, 2020
Primary completion
Dec 2024 (estimated)
Completion
May 2025 (estimated)
Last update
Aug 1, 2024

Study contacts

Yan zhiping, M.D.
principal investigator · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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