Fruquintinib as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 25, 2023

Primary Completion Date

August 1, 2025

Study Completion Date

July 1, 2026

Conditions
Esophageal Squamous Cell Carcinoma
Interventions
DRUG

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."

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER