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

NCT06370065 | Recruiting Phase 2

• 1 other identifier: HLX10IIT70-TJ
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR

  Defined as proportion of patients who have a best response of CR or PR

  up to 1year

Secondary Outcomes (2)

• PFS

  up to 1 year

• OS

  up to 2 years

Study Arms (1)

HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）

EXPERIMENTAL

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.

Drug: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）

Interventions

HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04） DRUG

PD-1 inhibitor

HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
• History of hepatic encephalopathy
• History of GI bleeding within 6 months, or investigator defined with high risk of haemorrhage for esophageal varices
• With distant metastasis (hilar lymph nodes metastasis is allowed)
• Co-infection of HBV and HCV
• History of other malignancy within 5 years except for healed local tumor.
• History of or plan to accept allogenic organ transplantation
• Ascites requiring invasive intervention (e.g. paracentesis) to maintain symptomatic control (every month or more often)
• History of myocardial infarction or unstable angina or uncontrolled arrythmia or stroke or cerebral hemorrhage within 6 months prior to randomization. QTcF value ≥450ms（male）or ≥470ms（female） detected by 12-lead electrocardiogram.
• New York Heart Association Grade ≥2 congestive heart failure or LVEF \<50%
• Uncontrolled hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• Active infection including but not limited to tuberculosis and HIV
• With interstitial lung disease, lung fibrosis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and serious impairment in lung function
• Active autoimmune disorders except patients with substitutional treatment with thyroid hormone and type I diabetes under treatment with insulin.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Central Study Contacts

Huikai Li, MD

CONTACT

18622228639; tjchlhk@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2024
• First Posted: April 17, 2024
• Study Start: April 27, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)