Lenvatinib Plus HAIC of Modified FOLFOX Regime vs Lenvatinib Plus HAIC of ROX Regime in Patients With Advanced HCC

• Status: Enrolling by invitation
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Lenvatinib Plus Hepatic Arterial Infusion of Modified FOLFOX Regime vs Lenvatinib Plus Hepatic Arterial Infusion of Oxaliplatin Plus Raltitrexed in Patients with Advanced Hepatocellular Carcinoma

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Collaborators: First Affiliated Hospital of Wenzhou Medical University; First Affiliated Hospital of Zhejiang University; Jinhua Central Hospital; Second Affiliated Hospital of Wenzhou Medical University; Shaoxing People's Hospital; The Third Affiliated Hospital of Wenzhou Medical University
• Treatments: Fluorouracil; Lenvatinib; Leucovorin; Oxaliplatin; Raltitrexed

Criteria

Inclusion Criteria:

1. Voluntary participation and informed consent, aged 18-75;

2. Patients with HCC confirmed by histopathology or meeting the clinical diagnostic criteria in the 2019 edition of the diagnostic and therapeutic criteria for primary liver cancer;

3. BCLC stage C patients with vascular invasion and without extrahepatic metastasis;

4. Child Pugh liver function classification: A or B grade;

5. ECOG physical strength score was 0-2 points;

6. No previous systemic or local treatment, and the expected survival time is more than 3 months;

7. According to recist1.1, the patient must have at least one measurable target lesion that has passed CT or MRI examination, and the tumor imaging evaluation was conducted within 2 weeks before receiving the study drug;

8. Full organ and bone marrow function: WBC ≥ 3.0 × 109/L； NE≥1.5 × 109/L； PLT≥75 × 109/L； Liver and kidney function ALT and AST ≤ 5uln; TBIL≤2ULN； Albumin ≥ 28g / L; Cr≤1.5 ULN； International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) exceeding the normal control range ≤ 4 seconds;

Exclusion Criteria:

1. Hepatocholangiocarcinoma, mixed cell carcinoma and fibrolamellar cell carcinoma are known;

2. Uncontrollable ascites, hepatic encephalopathy or esophageal variceal bleeding;

3. Patients with hypertension who can not be reduced to normal range after antihypertensive drug treatment (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);

4. Patients with myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia, myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmia (QTc interval ≥ 450 ms) (QTc interval was calculated by fridericia formula);

5. Patients with history of gastrointestinal bleeding or definite tendency of gastrointestinal bleeding in the past 3 months, such as esophageal varices with bleeding risk, local active ulcer lesions, fecal occult blood ≥ +, can not be included in the group;

6. Pregnant or lactating women, patients with fertility are unwilling or unable to take effective contraceptive measures;

7. patients with a history of HIV infection;

8. The researcher judges other situations that may affect the clinical research and the judgment of research results;