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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06010212
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin — DRUG
    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.

Study Details

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 .

Key Dates

First listed
Aug 24, 2023
Start date
Aug 25, 2023
Status verified
Aug 2023
Primary completion
Aug 1, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin

Primary Outcome Measure

ORR（Objective response rate） [ Time Frame: 1 year ]

Central Contacts

Related Studies