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

July 11, 2024 updated by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Hepatic Arterial Infusion of GEMOX Plus Systemic Gemcitabine Chemotherapy Combined With Lenvatinib and PD-1 Inhibitor in Large Unresectable Intrahepatic Cholangiocarcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

21

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
    • Guangzhou
      • Guangzhou, Guangzhou, China, 510000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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

No

Sampling Method

Probability Sample

Study Population

21 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.

Description

Inclusion Criteria:

(a) age of 18-70 years; (b) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; (c) diagnosis of ICC by histopathological examination of tissue biopsy specimens; (d) unresectable ICC confirmed by a multidisciplinary staff including at least one experienced liver surgeon; (e) tumor size larger than 5 cm in maximum diameter; (f) adequate liver function (total bilirubin < 3 times the upper limit of normal and aspartate/alanine transaminases < 5 times the upper limit of normal), adequate renal function (serum creatinine concentration of no more than 1.5 times the upper limit of the normal level), adequate bone marrow function (white blood cell count>3,000/mm3, hemoglobin>9.0g/dl and platelet count >100,000/mm3 ) and adequate coagulation function (prothrombin activity > 40% and international normalized ratio (INR) < 1.26); (g) patients received at least two cycles of GEMOX-HAIC + GEM-SYS combined with lenvatinib and PD-1 inhibitor; (h) patients with regular clinical data for evaluating the clinical efficacy and safety.

Exclusion Criteria:

(a) combined with other malignancies; (b) patients underwent any other chemotherapy regimens before, including gemcitabine and oxaliplatin; (c) patients received previous surgical resection or any other interventional procedures besides HAIC, such as transarterial chemoembolization (TACE), 125I seed implantation, radiofrequency ablation, microwave ablation, cryoablation, or percutaneous ethanol injection, etc.; (d) drug (chemotherapy drugs, lenvatinib, or PD-1 inhibitors) allergy; (e) patients with a history of autoimmune diseases; (f) patients with gastrointestinal bleeding of any grade within 4 weeks prior to the integrated treatment; (g) patients with uncontrolled comorbidities (e.g. general infection, serious dysfunction of heart or kidney, acute hepatitis or pneumonia, chronic obstructive pulmonary disease, or recent stroke).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HAIC+SYS+LEN+PD-1i
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.
Other Names:
  • PD-1 inhibitor
  • lenvatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival(OS)
Time Frame: 1-, 2-, and 3-year
OS was calculated as the duration from the date of the first cycle of GEMOX-HAIC+GEM-SYS to the date of death or last date of follow-up.
1-, 2-, and 3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival (PFS)
Time Frame: 1-, 2-, and 3-year
PFS was defined as the duration from the date of the first cycle of GEMOX-HAIC+GEM-SYS to tumor lesion progression, death, or last follow-up, whichever came first.
1-, 2-, and 3-year

Collaborators and Investigators

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

Sponsor

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

Investigators

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

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)

July 10, 2024

Primary Completion (Estimated)

July 10, 2025

Study Completion (Estimated)

July 10, 2025

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSKY-2024-539-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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