Status:
NOT_YET_RECRUITING
Liposomal Irinotecan and 5-FU as Second-line Therapy for Patients With ESCC
Lead Sponsor:
Rui-hua Xu, MD, PhD
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 (...
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 Comprehensi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06501664
Start Date
August 1 2024
End Date
November 30 2027
Last Update
July 15 2024
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