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

NCT06501664 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: CSPC-DEY-ESCC-K01
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Esophageal Cancer

Keywords

liposomal irinotecan; second-line therapy; esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Defined as the time between the date of randomization and death due to various causes

  1 year

Secondary Outcomes (4)

• Objective Response Rate

  4 months

• Disease Control Rate

  4 months

• Progress-free survival

  5 months

• Incidence of adverse events

  5 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

liposomal irinotecan+5-FU/LV q2w

Drug: liposomal irinotecan; Drug: 5-FU; Drug: LV

Control group

ACTIVE COMPARATOR

Irinotecan q2w or irinotecan+5-FU/LV q2w

Drug: 5-FU; Drug: LV; Drug: Irinotecan

Interventions

liposomal irinotecan DRUG

Liposomal irinotecan 70 mg/m²

Also known as: Nal-IRI

Experimental Group

5-FU DRUG

5-FU 400 mg/m² bolus then 2400 mg/m2 over 46 h

Also known as: Fluorouracil

Control group; Experimental Group

LV DRUG

LV 400 mg/m²

Also known as: Calcium folinate

Control group; Experimental Group

Irinotecan DRUG

Irinotecan 180 mg/m²

Also known as: IRI

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rui-hua Xu, MD, PhD: lead

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

irinotecan sucrosofate; Fluorouracil; Leucovorin; Irinotecan

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Camptothecin; Alkaloids

Study Officials

• Ruihua Xu, Professor

  Yat-sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huiyan Luo, Professor

CONTACT

020-87343804; luohy@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share