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HAIC Combined With PD-L1 Plus Regorafenib in the Treatment of Advanced Hepatocellular Carcinoma After Immunotherapy Failure

NCT06375317 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-04-19

No results posted yet for this study

Summary

For patients with advanced liver cancer who have progressed after first-line targeted and immunotherapy , there is currently no standard treatment regimen for second-line therapy. this study aims to explore the efficacy and safety of HAIC combined with PD-L1 and Regorafenib in patients with advanced liver cancer who have failed immunotherapy, not only providing new treatment options for second-line therapy of liver cancer, but also laying the foundation for research on the combination of HAIC and PD-L1 inhibitors plus Regorafenib, which has significant scientific research significance and clinical value.

Conditions

  • HCC - Hepatocellular Carcinoma

Interventions

DRUG

PD-L1 inhibitor: Adebrelimab Injection；Regorafenib Tablets

PD-L1 injection: 20 mg/kg, administered every 3 weeks (Q3W). Regorafenib: 80 mg, orally, once daily (qd), continuously for 14 days per cycle, followed by a 7-day rest period, administered every 3 weeks (Q3W). FOLFOX regimen: Oxaliplatin 85 mg/m2, Calcium folinate 400 mg/m2, Fluorouracil 400 mg/m2 as an IV bolus, followed by Fluorouracil 1200 mg/m2 infusion over 23 hours, administered every 3 weeks (Q3W) for a total of 6 cycles. The above doses are recommended doses.

Sponsors & Collaborators

  • Yehua Shen

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-04-30
Completion
2026-10-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06375317 on ClinicalTrials.gov