Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma

NCT06491134 | Not Yet Recruiting Phase 1

• 1 other identifier: HESS-LAEC-202401
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

Observation of maximum tolerable dose (MTD), dose limiting toxicity (DLT), and phase II clinical recommended dose (RP2D) of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal squamous cell carcinoma. Evaluate the efficacy and safety of liposomal irinotecan With Cisplatin and Concurrent Radiotherapy in the treatment of locally advanced esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

liposomal irinotecan; Cisplatin; Radiotherapy; Locally Advanced Esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• maximum tolerable dose (MTD)

  The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Objective response rate (ORR)

  Within 28 days of the end of treatment

• Progress-free survival(PFS)

  2-years

Study Arms (1)

liposomal irinotecan

EXPERIMENTAL

liposomal irinotecan With Cisplatin and Concurrent Radiotherapy

Drug: Liposomal Irinotecan Hydrochloride

Interventions

Liposomal Irinotecan Hydrochloride DRUG

liposomal irinotecan With Cisplatin and Concurrent Radiotherapy

liposomal irinotecan

Eligibility Criteria

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

You may qualify if:

• Understand and be willing to sign written informed consent and be able to follow research protocols for treatment.
• Age 18-75 years.
• Histologically confirmed cT2-T4a,N0-N+,M0 Esophageal Squamous Carcinoma.
• Existence of measurable and/or unmeasurable lesions that meet the criteria for evaluating the efficacy of solid tumors (RECIST 1.1)
• No previous anti-tumor therapy for esophageal cancer
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Life expectancy ≥ 3months
• Adequate organ and bone marrow function measured within14 days prior to administration of study treatment as defined below:
• Haemoglobin ≥ 90g/dL Absolute neutrophil count (ANC) ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Total bilirubin ≤institutional upper limit of normal Aspartate aminotransferase (AST(SGOT)/Alanine transaminase (ALT)SGPT) ≤ 2.5 x institutional upper limit of normal Serum creatinine ≤ 1.2mg/dL And creatinine clearance ≥50mL/min (Cockcroft-Gault formula)
• Women who are not pregnant or lactating. During the study period and within 6 months of the end of the study treatment, childbearing age Women/men should take effective contraceptive measures.

You may not qualify if:

• patients with other malignant tumors within the previous 5 years, except for cure carcinoma in situ, skin basal cell carcinoma.
• Allergic to cisplatin.
• Patients with a history of esophageal squamous cell carcinoma surgery.
• A history of fistula caused by primary tumor infiltration.
• Have higher, esophageal fistula or esophageal perforation of gastrointestinal bleeding risk.
• Poor nutritional status, BMI \< 18.5kg/m2, or PG-SGA score ≥9.
• Pulmonary fibrosis or interstitial pneumonia was diagnosed within 28 days before enrollment.
• Patients with active hepatitis B, hepatitis C, syphilis.
• major cardiovascular disease, including any of the following:
• Within 6 months before enrollment, congestive heart failure (defined as New York Heart Association grade III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass grafting, cerebrovascular accident, or hypertensive crisis.
• A history of clinically significant ventricular arrhythmias
• Friderica-modified QT interval \>450 msec in men and \>470 msec in women
• History of congenital long QT syndrome or family history
• Arrhythmias requiring antiarrhythmic drug therapy
• History of deep vein thrombosis, pulmonary embolism, or any other major thromboembolism within 3 months before enrollment

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jun Wang, Phd

CONTACT

13931182128; wangjunzr@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: offices director

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 8, 2024
• Study Start: June 27, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): February 28, 2028
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share