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NOT YET RECRUITING
NCT06010212
PHASE1/PHASE2

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

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

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 .

Official title: Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2023-08-25

Completion Date

2026-07-01

Last Updated

2023-08-24

Healthy Volunteers

No

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.