Efficacy and Safety of Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients

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

Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Willing to attend the study and having given the ICF

• Age ≥18

• Have a HCC diagnosis confirmed by radiology, histology, or cytology HCC is diagnosed at Barcelona Clinic Liver Cancer (BCLC) Stage C

• Have not accepted any of systemic therapy for HCC such as systemic chemotherapy, molecular targeted drugs, immunotherapy.

• At least 1 measurable intrahepatic lesion suitable for repeat assessments according to RECISTv1.1 criteria and it has not undergone surgery, radiology and/or other regional therapy (including but not limited to radiofrequency ablation, percutaneous ethanol injection, freezing therapy, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization). But if it progressed after the regional therapy, it could be selected as a target lesion. The local regional therapy must be done 4 weeks before randomization and the related AEs must recover to ≤ CTCAE grade 1.

• Child-Pugh score ≤7

• Eastern Cooperative Oncology Group (ECOG) 0 or 1

• Expected life time is over 12 weeks.

• HBV-DNA \< 2000 IU/mL

⁃ Organs function:

‣ Platelet count ≥75×109/L Absolute neutrophil count (ANC) ≥1.5×109 /L White blood cell count ≥3.0×109 /L Haemoglobin ≥9.0 g/dL Serum total bilirubin ≤1.5×ULN ALT ≤5×ULN, and AST ≤5×ULN(ALT ≤3×ULN, and AST ≤3×ULN, if HCV-RNA is detectable) Albumin ≥28 g/L INR ≤1.5×ULN PT ≤1.5×ULN APTT ≤1.5×ULN Creatinine clearance (CL) \>50 mL/min or serum creatinine ≤1.5×ULN Urine protein ≤1+ or ≤1.0g/24h 12. Patient is not fertile or willing and able to obey effective contraception

Locations
Other Locations
China
Tianjin Cancer Hospital Airport Hospital
RECRUITING
Tianjin
Contact Information
Primary
Huikai Li, MD
tjchlhk@126.com
18622228639
Time Frame
Start Date: 2023-04-27
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 35
Treatments
Experimental: HAIC+Serplulimab(HLX10)+ Bevacizumab Biosimilar(HLX04)
Procedure: HAIC (Hepatic arterial infusion chemotherapy) Drug: HLX10 (PD-1 antibody) Drug: HLX04 (VEGF antibody) HAIC: FOLFOX, q3w, up to 8 times; HLX10: 4.5mg/kg, iv, q3w, ; HLX04: 10mg/kg, iv, q3w.
Related Therapeutic Areas
Sponsors
Leads: Tianjin Medical University Cancer Institute and Hospital

This content was sourced from clinicaltrials.gov