Clinical trial · Interventional
Lenvatinib Plus HAIC of Modified FOLFOX Regime vs Lenvatinib Plus HAIC of ROX Regime in Patients With Advanced HCC
Lenvatinib Combined With Hepatic Arterial Infusion of Modified FOLFOX Regimen Versus Lenvatinib Combined With Hepatic Arterial Infusion of ROX Regimen in the Treatment of Advanced Hepatocellular Carcinoma
NCT05007587CI-TRIAL-00053300unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma Stage IIIa | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenvatinib | Drug | Lenvatinib | ALIAS |
| mFOLFOX regimen | Drug | — | UNRESOLVED |
| ROX regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lenvatinib,Then HAIC of mFOLFOX regimen
- description
- Cohort1:Participants were treated with 8mg lenvatinib (weight\<60kg) or 12mg lenvatinib (weight\>60kg) orally once daily on days 1 through 21, and HAIC regimen was performed every 3 weeks. The mFOLFOX regimen was administered via hepatic artery: oxaliplatin , 85mg/m2 , from hour 0 to 2 on day1 ; leucovorin , 400mg/m2 , from hour 2 to 3 on day 1 ; fluorouracil , 400mg/m2 , bolus at hour 3 ; and 2400mg/m2 over 46 hours on days 1 and 2.
- interventionNames
- Drug: Lenvatinib
- Drug: mFOLFOX regimen
- type
- EXPERIMENTAL
- label
- Lenvatinib,Then HAIC of ROX regimen
- description
- Cohort2:Participants were treated with 8mg lenvatinib (weight\<60kg) or 12mg lenvatinib (weight\>60kg) orally once daily on days 1 through 21, and HAIC regimen was performed every 3 weeks. The ROX regimen was administered via hepatic artery: oxaliplatin , 100mg/m2 , from hour 0 to 4 on day1 ;raltitrexed , 3mg/m2 , from hour 4 to 5 on day 1.
- interventionNames
- Drug: Lenvatinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (11)
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