The goal of this clinical trial is to evaluate the safety, tolerance and efficacy of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who failed Standard first line therapy.
Patients with advanced or recurrent esophageal carcinoma who failed standard first-line therapy have a low survival prognosis. There are few treatment options available and the clinical need is great. The aim of this study is to evaluate the efficacy and safety of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who fail first line therapy. The trial is a single arm design. Patient in the treatment group will accept Utidelone at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d administered orally on days 1-14, 21 days as one cycle. Before the use of utidelone, all patients will accept pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. Tumor assessments will be performed at baseline and every 6 weeks (±7 days) after enrollment and will continue until disease progression according to RECIST v1.1 criteria. For patients with no disease progression, tumor evaluation will continue regardless of treatment discontinuation unless the patient begins new antitumor therapy or withdraws informed consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. Utidelone will be given at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d took orally on days 1-14 every 21 days.
The First Affiliated Hospital of Xinxiang Medical University
Weihui, Henan, China
NOT_YET_RECRUITINGSuining Central Hospital
Suining, Sichuan, China
NOT_YET_RECRUITINGBeijing Cancer Hospital, Beijing, China
Beijing, China
RECRUITINGObjective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants
ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.
Time frame: Up to 1 year
progression-free survival (PFS) per RECIST 1.1 in all participants
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 or death due to any cause, whichever occurs first. For this analysis, PFS will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.
Time frame: Up to 1 year
duration of response (DOR) per RECIST 1.1 in all participants who achieve partial response (PR) or complete response (CR)
DOR is defined as the interval from response initiation (when either CR or PR is first determined) to progression or death, whichever occurs first.
Time frame: Up to 1 year
Overall survival (OS) in all participants
OS is defined as the time from randomization to death due to any cause. For this analysis, OS will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.
Time frame: Up to 2 years
Incidence of Treatment-Related Adverse Events
An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. The number of participants who experienced ≥1 AE will be presented.
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Time frame: Until 30 days after the last dose of treatment