An Exploratory Study to Evaluate the Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy (HAIC) Combine With Sintilimab and Donafenib for Unresectable Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-arm exploratory clinical study to evaluate the efficacy and safety of HAIC in combination with Sintilimab and Donafenib in patients with BCLC-C stage who have not received prior systemic therapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Written informed consent should be signed before implementing any trial-related procedures

• ECOG PS scores 0-1

• Histologically/cytologically confirmed HCC or cirrhosis meeting the clinical diagnostic criteria of HCC by American Association for the Study of Liver Diseases (AASLD)

• Barcelona Clinic Liver Cancer (BCLC) stage C

• Newly diagnosed HHC patients without any previous treatment for the tumor

• Child Pugh score of ≤ 7.

• Estimated survival \> 12 weeks

• At least one measurable lesion according to RECIST V1.1

• Sufficient organ and bone marrow functions

Locations
Other Locations
China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
RECRUITING
Wuhan
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 38
Treatments
Experimental: HAIC + Sintilimab + Donafenib
HAIC combine with Sintilimab and Donafenib
Related Therapeutic Areas
Sponsors
Leads: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

This content was sourced from clinicaltrials.gov