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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06364007

Enrollment

Registered

2024-04-12

Start date

2024-03-03

Completion date

2026-03-31

Last updated

2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

HAIC, uHCC, immunotherapy

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.

Interventions

DRUGHAIC+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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
ORR	about 1 year	objective response rate

Secondary

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

Countries

China

Contacts

Primary ContactChuang Peng, PhD

pengchuangcn@163.com15200850489

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026