Clinical trial NCT06364007: HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: HAIC
uHCC
immunotherapy
Lead sponsor: Hunan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ORR
timeFrame: about 1 year
Secondary outcomes:
measure: PFS
timeFrame: about 1.5 year
measure: OS
timeFrame: about 3 year
measure: DCR
timeFrame: about 1 year
measure: AE
timeFrame: about 3 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
state: Hunan
Study officials:
References: