NCT06364007

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sulai Liu · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	HAIC+STRIDE+Len	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).

Timeline

• Start date: 2024-03-03
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-04-12
• Last updated: 2024-04-12

Locations

1 site across 1 country: China