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

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

NCT ID: NCT06370065

Condition: Advanced Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）
Description: PD-1 inhibitor
Arm group label: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）

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

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Willing to attend the study and having given the ICF 2. Age ≥18 3. Have a HCC diagnosis confirmed by radiology, histology, or cytology HCC is diagnosed at Barcelona Clinic Liver Cancer (BCLC) Stage C 4. Have not accepted any of systemic therapy for HCC such as systemic chemotherapy, molecular targeted drugs, immunotherapy. 5. 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. 6. Child-Pugh score ≤7 7. Eastern Cooperative Oncology Group (ECOG) 0 or 1 8. Expected life time is over 12 weeks. 9. HBV-DNA < 2000 IU/mL 10. 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 Exclusion Criteria: 1. Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC 2. History of hepatic encephalopathy 3. History of GI bleeding within 6 months, or investigator defined with high risk of haemorrhage for esophageal varices 4. With distant metastasis (hilar lymph nodes metastasis is allowed) 5. Co-infection of HBV and HCV 6. History of other malignancy within 5 years except for healed local tumor. 7. History of or plan to accept allogenic organ transplantation 8. Ascites requiring invasive intervention (e.g. paracentesis) to maintain symptomatic control (every month or more often) 9. 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. 10. New York Heart Association Grade ≥2 congestive heart failure or LVEF <50% 11. Uncontrolled hypertension 12. History of hypertensive crisis or hypertensive encephalopathy 13. Active infection including but not limited to tuberculosis and HIV 14. With interstitial lung disease, lung fibrosis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and serious impairment in lung function 15. Active autoimmune disorders except patients with substitutional treatment with thyroid hormone and type I diabetes under treatment with insulin. 16. Receipt of live attenuated vaccine within 28 days prior to randomization 17. Current or prior use of steroids (>10mg/d prednisone) or immunosuppressive medication within 14 days before randomization 18. Significant traumatic injury or major surgical procedure within 28 days prior to randomization 19. Receipt of checkpoint inhibitors or T cell costimulatory drugs 20. Receipt of bevacizumab or its analogues 21. Involved in another clinical trial less than 14 days before randomization 22. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients 23. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control 24. Active bleeding, with history of ≥grade 3 bleeding within 6 months, or ≥grade 2 bleeding within 3 months 25. Use of anti-thrombotics within 5 days prior to randomization 26. In need of NSAIDs for long-term treatment. 26.With one of the following diseases within 6 months before randomization:(1) Digestive fistula, perforation and abscess (2) Gastrointestinal obstruction (3) Abdominal infection or inflammation (4) Major vascular disease 28. With severe and green wound, active ulcer or untreated fracture 29. History of drug abuse 30. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to screen for the study

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Cancer Hospital Airport Hospital

Address:
City: Tianjin
Country: China

Status: Recruiting

Contact:
Last name: Huikai Li, MD

Start date: April 27, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Tianjin Medical University Cancer Institute and Hospital
Agency class: Other

Source: Tianjin Medical University Cancer Institute and Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06370065