NCT06364007

HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

Name: Clinical Trial NCT06364007
Creator: Sulai Liu
Keywords: Hepatocellular Carcinoma, HAIC+STRIDE+Len, Phase 2, drug, clinical trial, China

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·Phase 2·ClinicalTrials.gov·drugRecruiting

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Study focus

Disease/Condition: Hepatocellular Carcinoma
Drug/Device/Intervention: HAIC+STRIDE+Len
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Sulai Liu
Funder: Hunan Provincial People's Hospital
Location: Changsha, China

Timeline & enrollment

Phase: Phase 2
Start date: Mar 03, 2024
End date: Mar 31, 2026
Enrollment: 20 participants

Primary outcome

ORR

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.

ICD-10 classifications

Malignant neoplasm: HepatoblastomaMalignant neoplasm: Liver cell carcinomaMalignant neoplasm: Other specified carcinomas of liverMalignant neoplasm: Liver, unspecifiedMalignant neoplasm: Hepatic flexure

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06364007
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT06364007 through Pure Global AI's free database. This Phase 2 trial is sponsored by Sulai Liu and is currently Recruiting. The study focuses on Hepatocellular Carcinoma. Target enrollment is 20 participants.

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