This Study is a Single-center, Single-arm, Phase II Clinical Study. The Primary Objective is to Evaluate the Efficacy and Safety of Fruquintinib, Carrelizumab, Paclitaxel Liposomes combined with Nidaplatin as First-line Treatment in Advanced Esophageal squamous cell carcinoma .
Not provided
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Phase Ib: Patients with advanced ESCC will be enrolled in a 3+3 dose escalation fashion, with projected enrolment of between 9-18 patients to determine RP2D. Once the RP2D is confirmed, the study will proceed to phase II. fruquintinib: 3 mg, 4 mg, or 5 mg qd p.o., 2 weeks and 1 week, every 3 weeks ( dose exploration phases were performed sequentially from the 4 mg group, refer to the study design section for specific protocols); Camrelizumab: 200 mg I.V D1, every 3 weeks for treatment cycles; Paclitaxel liposomes: 135 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles; Nidaplatin: 70 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles. Chemotherapy is used for up to 6 cycles, followed by maintenance therapy with fruquintinib + Camrelizumab until disease progression or intolerable toxicity. Phase II: Up to a total of 30 patients with advanced ESCC will be enrolled.
ORR(Objective response rate)
Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions.
Time frame: 1 year
DCR(Disease control rates)
Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, progressive disease (PD) is \>20% increase in sum of diameters of target lesions, stable disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 1 year
PFS(Progression-free survival)
PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =\>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is \>20% increase in sum of diameters of target lesions, Stable Disease (SD) is \<30% decrease or \<20% increase in sum of diameters of target lesions.
Time frame: 1 year
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