Actively Recruiting
GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-07-17
21
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
GEMOX-HAIC Plus GEM-SYS in Combination With Lenvatinib and PD-1 Inhibitor for Large Unresectable ICC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years
- ECOG performance status score of 0 or 1
- Diagnosis of intrahepatic cholangiocarcinoma confirmed by tissue biopsy
- Unresectable intrahepatic cholangiocarcinoma confirmed by a multidisciplinary team including a liver surgeon
- Tumor size larger than 5 cm in maximum diameter
- Adequate liver function: total bilirubin less than 3 times upper limit of normal, AST/ALT less than 5 times upper limit
- Adequate kidney function: serum creatinine no more than 1.5 times upper limit of normal
- Adequate bone marrow function: white blood cell count above 3,000/mm3, hemoglobin above 9.0 g/dl, platelet count above 100,000/mm3
- Adequate coagulation function: prothrombin activity above 40%, INR less than 1.26
- Patients received at least two cycles of GEMOX-HAIC plus GEM-SYS combined with lenvatinib and PD-1 inhibitor
- Patients have regular clinical data available for evaluating treatment efficacy and safety
You will not qualify if you...
- Presence of other malignancies
- Previous chemotherapy with gemcitabine and oxaliplatin
- Prior surgical resection or other interventional treatments besides HAIC, such as TACE, 125I seed implantation, radiofrequency ablation, microwave ablation, cryoablation, or ethanol injection
- Known allergy to chemotherapy drugs, lenvatinib, or PD-1 inhibitors
- History of autoimmune diseases
- Gastrointestinal bleeding within 4 weeks before treatment
- Uncontrolled serious medical conditions such as infections, heart or kidney failure, acute hepatitis or pneumonia, chronic obstructive pulmonary disease, or recent stroke
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangzhou, China, 510000
Actively Recruiting
Research Team
J
Jia-yan Ni, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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