The Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable HCC

Sponsor
Sichuan University
Study ID
NCT05042336
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Borderline Resectable Hepatocellular Carcinoma
  • Carrelizumab Plus Lenvatinib Combined With TACE

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The effectiveness and safety of carmelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma remain unknown. This subject is an open, single-arm, randomized, single-center, and phase Ib/II study according to simon's two phase design. In the phase Ib trial, the groups of patients were divided according to the frequency of camrelizumab: camrelizumab (q3w) plus lenvatinib and TACE group, certolizumab (q2w) plus lenvatinib and TACE group. In the phase II trial, the enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks for evaluation of surgical resection. If surgical resection is not possible, it is necessary to evaluate whether to continue TACE treatment. Afterwards, the imaging efficacy evaluation (RECISTv1.1) will be carried out every 6-8 weeks to evaluate whether to operate and determine the best operation time. If surgery is possible, choose to continue the treatment with camrelizumab and/or TACE according to the patient's condition after the operation until the disease progresses or intolerable toxicity, and the drug should be discontinued up to 2 years. Imaging examinations will be performed every 2-3 months within six months after the operation, and imaging examinations will be performed every 3-6 months after six months. Safety is based on physical examination, laboratory examination, drug-related adverse events, surgery-related adverse events, and serious adverse events. To explore the effectiveness and safety of camrelizumab/lenvatinib combined with TACE in patients with borderline resectable hepatocellular carcinoma, and to screen the predictive indicators of the efficacy and safety of the combined regimen.

Key Dates

Start date
Sep 1, 2021
Status verified
Sep 2021
Primary completion
Jun 1, 2023
Completion
Oct 1, 2023

Study Design

Enrollment
49 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: camrelizumab/lenvatinib combined with TACE
    Phase Ib trial： Ib-A group \[camrelizumab q3w group\]: TACE d1, camrelizumab 200mg, d1, 22, 43; Lenvatinib d7-43; Surgery d50; Group Ib-B \[camrelizumab q2w group\]: TACE d1, camrelizumab 200mg, d1, 15, 29; Lenvatinib d7-43; Surgery d50. Phase II trial： The enrolled patients received camrelizumab/lenvatinib combined with TACE treatment (a relatively safer treatment plan based on phase Ib), and the first imaging efficacy evaluation was performed at 6-8 weeks to evaluate surgical resection

Primary Outcome Measure

Adverse events [ Time Frame: through study completion, an average of 1 year ]

Central Contacts