36
Participants
Start Date
August 25, 2023
Primary Completion Date
August 1, 2025
Study Completion Date
July 1, 2026
Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin
"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."
The First Affiliated Hospital with Nanjing Medical University
OTHER