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GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC

NCT06505486 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2024-07-17

No results posted yet for this study

Summary

This study aimed to preliminarily evaluate the clinical efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor in patients with large unresectable intrahepatic cholangiocarcinoma (uICC). Large uICC patients who underwent GEMOX-HAIC (Day 1) and GEM-SYS (Day 8) (3w/cycle) combined with lenvatinib and PD-1 inhibitor between November 2019 and December 2022 were enrolled. Clinical data were retrospectively collected to analyze local tumor response, progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Tumor response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. AEs were evaluated by the common terminology criteria for adverse events (CTCAE) version 5.0. In this study, OS was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.

Conditions

  • Intrahepatic Cholangiocarcinoma

Interventions

DRUG

Gemcitabine-Oxaliplatin Regimen

Hepatic arterial infusion chemotherapy (HAIC) of gemcitabine and oxaliplatin (GEMOX) plus systemic gemcitabine chemotherapy (GEM-SYS) combined with lenvatinib and programmed cell death protein-1 (PD-1) inhibitor.

Sponsors & Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jia-yan Ni, M.D. · Sun Yat-sem Memorial Hospital, Sun Yat-sen University

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-10
Completion
2025-07-10

Countries

  • China

Study Locations

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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 NCT06505486 on ClinicalTrials.gov