Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06370065
Other study ID # HLX10IIT70-TJ
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 27, 2023
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source Tianjin Medical University Cancer Institute and Hospital
Contact Huikai Li, MD
Phone 18622228639
Email tjchlhk@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 31, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HAIC+Serplulimab(HLX10)+ Bevacizumab Biosimilar(HLX04)
PD-1 inhibitor

Locations

Country Name City State
China Tianjin Cancer Hospital Airport Hospital Tianjin Tianjin

Sponsors (1)

Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary ORR Defined as proportion of patients who have a best response of CR or PR up to 1year
Secondary PFS Defined as the time from enrollment to disease progression or death (whichever occurs first) up to 1 year
Secondary OS Defined as the time from enrollment to death from any cause up to 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05028933 - IMC001 for Clinical Research on Advanced Digestive System Malignancies Phase 1
Recruiting NCT05057845 - Cryoablation Combined With Tislelizumab Plus Lenvatinib as Second-line or Later Therapy in Advanced Hepatocellular Carcinoma Phase 2
Recruiting NCT02638857 - Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen Combined With Transcatheter Arterial Chemoembolization for the Treatment of Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT02632006 - Immunotherapy Using Pluripotent Killer-Programmed Cell Death 1 (PIK-PD-1) Cells for the Treatment of Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT00752063 - Sorafenib With Capecitabine and Oxaliplatin for Advanced or Metastatic Hepatocellular Carcinoma Phase 2
Completed NCT00517920 - Phase 2 Study of ABT-869 in Advanced Hepatocellular Carcinoma (HCC) Phase 2
Recruiting NCT05797805 - A Study of Tegavivint (BC2059) in Patients With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Active, not recruiting NCT05070156 - B010-A Injection for Treating Patients With GPC3 Positive Advanced Hepatocellular Carcinoma Early Phase 1
Not yet recruiting NCT06092112 - A Clinical Trial for the Safety and Efficacy of CD-801 in Patients With Advanced Hepatocellular Carcinoma Early Phase 1
Recruiting NCT01214343 - Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC Phase 3
Completed NCT00999882 - Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients Phase 1
Withdrawn NCT00756782 - A Study of TAC-101 in Combination With TACE Versus TACE Alone in Asian Patients With Advanced Hepatocellular Carcinoma Phase 2
Completed NCT00534664 - Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT04503902 - Toripalimab Combined With Donafenib in the Treatment of Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Terminated NCT04777708 - BO-112 and Pembrolizumab for the Treatment of PD-1/PD-L1 Refractory Liver Cancer Early Phase 1
Completed NCT04072679 - Safety and Efficacy Study of Sintilimab Combined With IBI305 in Patients With Advanced Hepatocellular Carcinoma Phase 1
Suspended NCT04066660 - Study of Oligo-Fucoidan in Advanced Hepatocellular Carcinoma (HCC) N/A
Withdrawn NCT05592197 - Safety and Efficacy of Radiation Plus TACE and Lenvatinib in Advanced HCC With PVTT N/A
Completed NCT02528643 - A Study to Assess the Efficacy and Safety of Enzalutamide in Subjects With Advanced Hepatocellular Carcinoma Phase 2
Active, not recruiting NCT04514484 - Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV Phase 1