Hepatocellular carcinoma
Conditions
Interventions
Trial group:Received QL1706 (7.5 mg/kg, IV, Q3W) in combination with HAIC-FOLFIRI (Irinotecan (120 mg/m^2, 30–90 min, d1), LV (400 mg/m^2, 2 h, d1), and 5-FU (1200 mg/m^2, maintained for 24–26 h). HAI
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 75 years; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0–1, Child-Pugh score =10 mm or malignant lymph node with shortest diameter >=15 mm); 5. Previous first-line treatment with transcatheter hepatic artery infusion chemotherapy (HAIC-FOLFOX) combined with targeted therapy and PD-1/PD-L1 inhibitors for hepatocellular carcinoma resulted in resistance or progression (as defined by RECIST 1.1); 6. Expected survival >=3 months; 7. Within 7 days prior to first dosing, laboratory tests meet the following criteria (no administration of blood components, hematopoietic growth factors, albumin, or other medications deemed corrective therapy by the investigator within 14 days prior): (1) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 50 mL/min (calculated using the Cockcroft-Gault formula); (2) Complete blood count: Hemoglobin (Hb) >=9.0 g/dL (no red blood cell transfusions within 1 week prior to baseline Hb testing, including the day of testing); Absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet count >=100×10^9/L (no platelet transfusions within 1 week prior to baseline platelet testing, including the day of testing); (3) Coagulation function: International Normalized Ratio (INR) =2+, 24-hour urine protein quantification must be <1 g/24h); 8. No contraindications to chemotherapy or immunotherapy; 9. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment and agree to use reliable and effective contraception during the trial and for 3 months after the last dose. Male subjects with female partners of childbearing potential must agree to use reliable and effective contraception during the trial and for 3 months after the last dose. Breastfeeding women are excluded; 10. Subjects must provide informed consent to this study prior to enrollment, voluntarily sign a written informed consent form, and be willing and able to comply with study visits, treatment plans, laboratory tests, and other study procedures as outlined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Diffuse hepatocellular carcinoma, fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, hepatocellular-cholangiocellular carcinoma, or other types of hepatobiliary malignancies confirmed by imaging or cytology; 2. History of any of the following immune therapy events: (1) any Grade 3 or higher immune-related adverse event (irAE); (2) any toxicity leading to permanent discontinuation of prior anti-PD-1/PD-L1 therapy; (3) patients assessed as having progressed within 1×10^3 copies/mL; 9. History of bleeding from esophageal or gastric varices due to portal hypertension within the past 6 months. Subjects assessed by the investigator as being at high risk for bleeding. Any life-threatening bleeding events within the past 3 months, including those requiring blood transfusion, surgery, local treatment, or ongoing medication; 10. History of arterial or venous thromboembolic events within the past 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, or any other serious thromboembolic event. Excludes thrombosis associated with implantable venous access devices or catheters, or stable superficial vein thrombosis following routine anticoagulant therapy. Low-dose prophylactic use of low molecular weight heparin (e.g., enoxaparin 40 mg/day) is permitted; 11. Continuous use of aspirin (>325 mg/day) or other known platelet function inhibitors such as clopidogrel or ticlopidine for 10 days within 2 weeks prior to first dose. Severe bleeding tendency or coagulation disorder, or currently undergoing thrombolytic therapy; 12. Presence of any toxicity from prior treatment not recovered to Grade 0 or 1 (excluding alopecia, clinically insignificant, and asymptomatic laboratory abnormalities) according to the National Cancer Institute Common Terminology Criteria for Adverse Events version
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Progression free survival;Overall survival;Incidence of adverse events;Incidence of Serious Adverse Events; | — |
Countries
China
Contacts
Public ContactChen Zhongwu
First Affiliated Hospital of Fujian Medical University
Outcome results
None listed