HAIC Combined With Durvalumab and Tremelimumab and Lenvatinib in uHCC

April 9, 2024 updated by: Sulai Liu

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Hunan Provincial People's Hospital(The First Affiliated Hospital of Hunan Normal University)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treating with a Designed Protocol
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: about 1 year
objective response rate
about 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sulai Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLiu0401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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