Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

Trial Title: Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC

NCT ID: NCT06501664

Condition: Esophageal Cancer

Conditions: Official terms:
Esophageal Squamous Cell Carcinoma
Leucovorin
Fluorouracil
Irinotecan

Conditions: Keywords:
liposomal irinotecan
second-line therapy
esophageal squamous cell carcinoma

Study type: Interventional

Study phase: Phase 3

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: liposomal irinotecan
Description: Liposomal irinotecan 70 mg/m²
Arm group label: Experimental Group

Other name: Nal-IRI

Intervention type: Drug
Intervention name: 5-FU
Description: 5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h
Arm group label: Control group
Arm group label: Experimental Group

Other name: Fluorouracil

Intervention type: Drug
Intervention name: LV
Description: LV 400 mg/m²
Arm group label: Control group
Arm group label: Experimental Group

Other name: Calcium folinate

Intervention type: Drug
Intervention name: Irinotecan
Description: Irinotecan 180 mg/m²
Arm group label: Control group

Other name: IRI

Summary: The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Detailed description: Esophageal cancer was ranked the sixth most common cancer worldwide and seventh most common cause of cancer-related deaths. ESCC is the most common histologic subtype in Asia. The National Comprehensive Cancer Network (NCCN) guidelines recommend immune checkpoint inhibitors, taxanes, fluorouracils and/or irinotecan as the second-line treatment of ESCC. Liposomal irinotecan is a new pharmaceutical form of traditional irinotecan. It adopts a special loading technology to encapsulate traditional irinotecan in liposomes, which can avoid its hydrolysis under physiological conditions, increase the affinity with cancer cells, overcome drug resistance, increase the drug uptake by cancer cells, reduce the drug dose, improve the efficacy and reduce the toxic side effects. The aim of this study is to compare the efficacy and safety of liposome irinotecan +5-FU and irinotecan / irinotecan +5-FU regimens in the second-line treatment of esophageal squamous cell carcinoma (ESCC).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Age: 18-75 years old. - Unresectable esophageal squamous cell carcinoma confirmed by histopathology and/or cytology. - Failure or intolerance to first-line treatment. - At least one measurable lesion (according to RECIST v1.1). - Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1. - The expected survival time ≥3 months. - Subject has adequate biological parameters as demonstrated by the following: absolute neutrophil count (ANC) ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin (Hgb) ≥90 g/L. - Adequate hepatic function as evidenced by total bilirubin ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN, ≤5 x ULN if liver metastases are present. Documented serum albumin ≥ 3 g/dL. - Adequate renal function as evidenced by serum creatinine (Cr)≤1.5 x ULN or creatinine clearance ≥60 mL/min. - Subjects agree to use contraception and are not pregnant or breastfeeding women. - Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening. Exclusion Criteria: - Any other malignancy within 5 years prior to randomization, with the exception of cured in-situ carcinoma or basal cell carcinoma. - Received irinotecan/irinotecan liposome based therapy in the first line. - Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment. - Active HIV infection. - Combined with uncontrollable systemic diseases, such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrolled hypertension(Defined as systolic blood pressure≥140 mmHg and/or diastolic blood pressure≥90 mmHg after treatment with standardized antihypertensive drugs), or history of critical hypertension, hypertensive encephalopathy; uncontrollable diabetes, etc. - Presence of severe gastrointestinal disease (including active bleeding, > grade 1 obstruction , > grade 1 diarrhea or gastrointestinal perforation) - Allergy to or intolerance to therapeutic drugs or their excipients. - Presence of central nervous system metastasis. - Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1. - Participated in other trial within 30 days or within 5 half-lives of the drug prior to the first dose of study treatment. - Patients who are not suitable to participate in this trial for any reason judged by the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Start date: August 1, 2024

Completion date: November 30, 2027

Lead sponsor:
Agency: Rui-hua Xu, MD, PhD
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06501664