Status:
NOT_YET_RECRUITING
HAIC Combine Tislelizumab and Lenvatinib in the Treatment of HCC With Type IV (Vp4) Portal Vein Tumor Thrombus (HAI-TL)
Lead Sponsor:
Li Xiao Wei
Conditions:
Hepatocellular Carcinoma With PVTT
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To estimate the safety and efficacy of hepatic artery infusion chemotherapy (HAIC) combine Tislelizumab and Lenvatinib (HAI-TIS-LEN) in the Treatment of hepatocellular carcinoma (HCC) with type IV(Vp4...
Detailed Description
According to the Chinese guidelines for the diagnosis and treatment of primary liver cancer, patients with hepatocellular carcinoma (HCC) accompanied by portal vein tumor thrombosis (PVTT) are classif...
Eligibility Criteria
Inclusion
- Histologically, cytologically, or clinically confirmed diagnosis of hepatocellular carcinoma (HCC).
- Age between 18 and 75 years.
- Presence of type 4 portal vein tumor thrombosis (PVTT).
- Child-Pugh A or B liver function.
- Eastern Cooperative Group performance status (ECOG) score of 0-2.
- Satisfactory blood, liver, and kidney function parameters, including:
- (a) Hemoglobin concentration ≥ 8.5 g/dL, neutrophil count ≥ 1.5 × 10\^9/L, platelet count ≥ 40 × 10\^9/L.
- (b) Serum albumin concentration ≥ 30 g/L, bilirubin ≤ 50 μmol/L, AST and ALT \< 5 × upper limit of normal (ULN), and alkaline phosphatase \< 4 × ULN.
- (c) Extended prothrombin time \< 6 seconds of ULN.
- (d) Serum creatinine \< 1.5 × ULN.
- Ability to comprehend the protocol and provide informed consent by signing a written document.
Exclusion
- History of a second primary malignant tumor.
- Severe dysfunction of the heart, kidneys, or other organs.
- Evidence of hepatic decompensation, including ascites, active gastrointestinal bleeding, or hepatic encephalopathy.
- Pregnancy or lactation.
- Known history of HIV.
- History of organ allograft.
- Known or suspected allergy to investigational agents or any agent administered in conjunction with this trial.
- Active gastric or duodenal ulcers within 3 months before enrollment.
- Incomplete medical data or loss to follow-up.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT06210334
Start Date
March 1 2024
End Date
January 1 2026
Last Update
February 20 2024
Active Locations (1)
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1
Eastern Hepatobiliary Surgery Hospital
Yangpu, Shanghai Municipality, China