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Trial Title:
HAIC+Lenvatinib+Tislelizumab vs D-TACE+Lenvatinib+Tislelizumab for Unresectable HCC
NCT ID:
NCT05582278
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Lenvatinib
Tislelizumab
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
D-TACE
Description:
CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization:
Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is
still visible after the embolization with one vial of beads, regular microspheres
(8spheres) with diameters of 100-700 μm are additionally injected.
Arm group label:
D-TACE+lenvatinib+tislelizumab
Other name:
D-TACE+lenvatinib+tislelizumab
Intervention type:
Drug
Intervention name:
HAIC
Description:
FOLFOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 100 mg/m2
infusion for 2 hours; calcium levofolinate, 200 mg/m2 infusion for 1 hours; and 5-FU, 400
mg/m2 bolus infusion and then 2400 mg/m2 continuous infusion over 46 h.
Arm group label:
D-TACE+lenvatinib+tislelizumab
Arm group label:
HAIC+lenvatinib+tislelizumab
Other name:
HAIC+Lenvatinib+tislelizumab
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
12 mg/d for bodyweight ⩾ 60 kg or 8 mg/d for bodyweight <60 kg
Arm group label:
D-TACE+lenvatinib+tislelizumab
Arm group label:
HAIC+lenvatinib+tislelizumab
Other name:
Targeted therapy
Intervention type:
Drug
Intervention name:
tislelizumab
Description:
tislelizumab 200 mg, every 3 weeks.
Arm group label:
HAIC+lenvatinib+tislelizumab
Other name:
PD-1 inhibitors
Summary:
Drug-eluting Bead-Transarterial chemoembolization (D-TACE) is the most widely used
palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of
studies demonstrate poor effect of D-TACE for patients in Advanced Unresectable HCC. The
investigators previous study also revealed similar results in Advanced Unresectable HCC
patients treated with D-TACE. Recently, the investigators previous study demonstrated
that, compared with D-TACE, hepatic arterial infusion chemotherapy (HAIC) may improve
tumor response in Advanced Unresectable HCC. Thus, the investigators carried out this
prospective nonrandomized control to demonstrate the superiority of HAIC-based
combination therapy over D-TACE-based combination therapy.
Detailed description:
HCC is one of the most common malignant tumors with the worst prognosis. At present,
except for liver transplantation, surgical resection is the most effective therapy for
patients with HCC. However, many patients are found to have advanced cancer as soon as
they were diagnosed and lose the opportunity of radical resection and treatments are
limited.More and more clinical research failures have hit the investigators' hard, until
a clinical study named IMbrave150, published in the New England Journal of Medicine in
2020. It has opened up a new era of combination therapy, breaking the pattern of only a
single mode of advanced liver cancer for more than ten years, making the investigators
realize that for the treatment of patients with advanced liver cancer, the single
treatment effect is often very limited, and combination therapy is the future.The
investigators recent research showed that HAIC Combined With Lenvatinib and Tislelizumab
brings good results to patients with advanced HCC.To identify a more effective and safety
way for treating potentially resectable HCC patients, this study is designed to compare
the safety and efficacy between HAIC-based combination therapy and D-TACE-based
combination therapy for those patients in Advanced Unresectable HCC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with advanced unresectable hepatocellular carcinoma treated by D- TACE, or
HAIC combined with Lenvatinib and Tislelizumab as initial treatment
- Age between 18 and 75 years
- Child-Pugh A or B liver function
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate hematologic blood counts (white blood cell count >3ⅹ109/L, absolute
neutrophil count >1.5ⅹ109/L, platelet count >10ⅹ109/L, hemoglobin concentration >85
g/L
- No extrahepatic metastasis
Exclusion Criteria:
- Severe underlying cardiac, pulmonary, or renal diseases
- History of a second primary malignant tumor
- Incomplete medical data
- Loss to follow-up.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen Li, PHD
Phone:
18870050597
Email:
lw1042@126.com
Contact backup:
Last name:
Lu Fang, PHD
Phone:
13507911672
Email:
fanglu@medmail.com.cn
Start date:
January 1, 2021
Completion date:
January 1, 2024
Lead sponsor:
Agency:
Wen Li
Agency class:
Other
Source:
Second Affiliated Hospital of Nanchang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05582278
