HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

NCT ID: NCT06364007

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-03
• Study Completion Date: 2026-03-31

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treating with a Designed Protocol

Group Type: EXPERIMENTAL

HAIC+STRIDE+Len

Intervention Type: DRUG

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).

Interventions

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).

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sulai Liu

OTHER

Sponsor Role: lead

Responsible Party

Sulai Liu

Hepatobiliary Surgical Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuang Peng, PhD

Role: CONTACT

pengchuangcn@163.com

15200850489

Facility Contacts

Chuang Peng, PhD

Role: primary

pengchuangcn@163.com

15200850489

Other Identifiers

SLiu0401

Identifier Type: -

Identifier Source: org_study_id