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

NCT ID: NCT06505486

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-07-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

HAIC+SYS+LEN+PD-1i

Gemcitabine-Oxaliplatin Regimen

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

lenvatinib; PD-1 inhibitor

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia-yan Ni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sem Memorial Hospital, Sun Yat-sen University

Locations

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

Guangzhou, Guangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia-yan Ni, M.D.

Role: CONTACT

nijaiyan3@mail.sysu.edu.cn

13660140273

Facility Contacts

Jia-yan Ni

Role: primary

nijiayan3@mail.sysu.edu.cn

13660140273

Other Identifiers

SYSKY-2024-539-01

Identifier Type: -

Identifier Source: org_study_id