HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
Phase II Study Evaluating the Efficacy of Tremelimumab (T) Plus Durvalumab (D) With Lenvatinib Combined With Concurrent Hepatic Arterial Infusion Chemotherapy (HAIC) in Patients (Pts) With Unresectable Hepatocellular Carcinoma (uHCC)
Sulai Liu
20 participants
Mar 3, 2024
INTERVENTIONAL
Conditions
Summary
The treatment options for unresectable HCC have rapidly developed, and immunotherapy has shown significant survival benefits in hepatocellular carcinoma. The STRIDE regimen of Single Tremelimumab (high, priming 300-mg dose) Regular Interval Durvalumab (1500 mg every 4 weeks) improved OS vs sorafenib in pts with unresectable HCC. In Asian region, HAIC is applied for HCC patients who are not suitable for surgical resection or local ablation treatment. Retrospective studies suggested a potent antitumor effect and survival benefit of HAIC plus programmed death-1 inhibitor and Lenvatinib. This phase II study was aimed to evaluate the efficacy and safety of STRIDE plus lenvatinib, given concurrently with HAIC in pts with unresectable HCC.
Eligibility
Inclusion Criteria20
- Age 18 \~ 70 years old (including 70 years old), male and female;
- Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;
- Patients with unresectable or metastatic hepatocellular carcinoma;
- No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;
- Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;
- At least one assessable lesion (mRECIST criteria);
- Expected survival time ≥ 3 months;
- ECOG 0 \~ 1;
- Child Pugh ≤ 7;
- Be able to cooperate to observe adverse events;
- Major organs are functioning normally:
- Hemoglobin ≥ 90 g / L;
- ANC ≥ 1.5 × 109/L；
- Platelet count ≥ 75 × 109/L；
- Albumin ≥ 28 g / L;
- Total bilirubin ≤ 2 × ULN;
- AST, ALT ≤ 5 × ULN；
- ALP ≤ 5 × ULN；
- Creatinine ≤ 1.5 × ULN；
- INR or PT ≤ 1.5 × ULN； J) APTT ≤ 1.5 × ULN。
Exclusion Criteria5
- History of symptomatic congestive heart failure, unstable angina pectoris,
- Uncontrolled cardia arrhythmia
- History of hepatic encephalopathy
- Uncontrolled arterial hypertension
- Co-infection with HBV and HDV
Interventions
patients will be administrated with STRIDE plus lenvatinib (8 mg or 12 mg) once daily plus HAIC- modified FOLFOX (oxaliplatin, 85 mg/m2; leucovorin, 400 mg/m2; 5-fluorouracil bolus, 400 mg/m2 on day 1; 5-fluorouracil infusion, 2400 mg/m2 for 46 h).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06364007