A Phase II Clinical Study of Fruquintinib Combined With S-1 for Advanced Esophageal Squamous Cell Carcinoma

NCT05636150 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-12-05

No results posted yet for this study

Summary

Investigators conduct the clinical trial to further explore the efficacy and safety of Fruquintinib combined with S-1 in treating recurrent or metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.

Conditions

Interventions

DRUG

Fruquintinib in Combination with S-1

Cohort A: Fruquintinib 3 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort B: Fruquintinib 4 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Cohort C: Fruquintinib 5 mg QD, oral dosing, 2 weeks on/1 weeks off+ S-1 40-60mg/time bid po d1-14 q3w. Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Zhao Lin, MD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2024-03-30
Completion
2024-08-30

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636150 on ClinicalTrials.gov