Liposomal Irinotecan Hydrochloride
Drugliposomal irinotecan With Cisplatin and Concurrent Radiotherapy
NCT Number: NCT06491134
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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)
Exclusion criteria
liposomal irinotecan With Cisplatin and Concurrent Radiotherapy
Time frame: through study completion, an average of 1 year
The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing dose-limiting
Time frame: Within 28 days of the end of treatment
The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR
Time frame: 2-years
Progression-free survival will be measured from the start of treatment until the first documentation of confirmed disease progression or death due to any cause, whichever occurs first.
Contact information is provided by the study sponsor or research team.
Hebei Medical University Fourth Hospital
Other
Phase Ib Trial of Liposomal Irinotecan With Cisplatin and Concurrent Radiotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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