HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

Phase 2

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: HAIC+STRIDE+Len

• Registration Number: NCT06364007
• Lead Sponsor: Sulai Liu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-03
• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18 ~ 70 years old (including 70 years old), male and female;

2. Patients with hepatohcellular carcinoma diagnosed clinically or confirmed by histology / cytology ;

3. Patients with unresectable or metastatic hepatocellular carcinoma;

4. No systematic treatment. Patients recieved previously systematic treatment and progressed can also be included in the group;

5. Patients who underwent hepatectomy in the past should be R0 resection, and the tumor recurrence should be more than 6 months after operation;

6. At least one assessable lesion (mRECIST criteria);

7. Expected survival time ≥ 3 months;

8. ECOG 0 ~ 1;

9. Child Pugh ≤ 7;

10. Be able to cooperate to observe adverse events;

11. 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 Criteria

1. History of symptomatic congestive heart failure, unstable angina pectoris,
2. Uncontrolled cardia arrhythmia
3. History of hepatic encephalopathy
4. Uncontrolled arterial hypertension
5. Co-infection with HBV and HDV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treating with a Designed Protocol	HAIC+STRIDE+Len	-

Primary Outcome Measures

Name	Time	Method
ORR	about 1 year	objective response rate

Secondary Outcome Measures

Name	Time	Method
PFS	about 1.5 year	progression-free survival
OS	about 3 year	overall survival
AE	about 3 year	adverse events
DCR	about 1 year	disease control rate

Trial Locations

Locations (1)

Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University); 🇨🇳 Changsha, Hunan, China