NCT05042336

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

A Phase Ib/Ⅱ Clinical Study to Explore the Effectiveness and Safety of Camrelizumab/Lenvatinib Combined With TACE in Patients With Borderline Resectable Hepatocellular Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Sichuan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	camrelizumab/lenvatinib combined with TACE	Lenvatinib 4mg qd body weight≤60,8mg；body weight\>60,12mg Camrelizumab 200mg q2w/q3w

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-06-01
• Completion: 2023-10-01
• First posted: 2021-09-13
• Last updated: 2021-09-13

Locations

1 site across 1 country: China