HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

Hepatocellular Carcinoma Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364007
• Other study ID #: SLiu0401
• Status: Recruiting
• Phase: Phase 2
• Start date: March 3, 2024
• Est. completion date: March 31, 2026

Study information

• Verified date: April 2024
• Source: Hunan Provincial People's Hospital
• Contact: Chuang Peng, PhD
• Phone: 15200850489
• Email: pengchuangcn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• HAIC+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).

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Sulai Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	objective response rate	about 1 year
Secondary	PFS	progression-free survival	about 1.5 year
Secondary	OS	overall survival	about 3 year
Secondary	DCR	disease control rate	about 1 year
Secondary	AE	adverse events	about 3 year