Combination Therapy of HAIC and HLX10 and HLX04 in HCC With Major Portal Vein Tumor Thrombosis (NCT04947826) | Clinical Trial Compass
UnknownPhase 2
Combination Therapy of HAIC and HLX10 and HLX04 in HCC With Major Portal Vein Tumor Thrombosis
100 participantsStarted 2021-08
Plain-language summary
This is a randomized, double-blinded, controlled, phase II study. The purpose is to evaluate efficacy and safety of the combination therapy of HAIC (Hepatic arterial infusion chemotherapy) with HLX10 (PD-1 antibody) and HLX04 (VEGF antibody) compared with HAIC and placebo in patients with hepatocellular carcinoma with major portal vein tumor thrombosis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 with major portal vein tumor thrombosis ( VP3～4, or Cheng's II～IV)
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Objective response rate
Timeframe: The proportion of patients with complete response or partial response, through study completion, an average of 3 years.