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HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC - Trial NCT06364007

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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NCT06364007
Phase 2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06364007
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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)

Study Focus

Hepatocellular Carcinoma

HAIC+STRIDE+Len

Interventional

drug

Sponsor & Location

Sulai Liu

Hunan Provincial People's Hospital

Changsha, China

Timeline & Enrollment

Phase 2

Mar 03, 2024

Mar 31, 2026

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: Hepatoblastoma
Malignant neoplasm: Liver cell carcinoma
Malignant neoplasm: Other specified carcinomas of liver
Malignant neoplasm: Liver, unspecified
Malignant neoplasm: Hepatic flexure

Data Source

ClinicalTrials.gov

NCT06364007

Non-Device Trial