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A Phase lb/lI Clinical Study in Advanced or Metastatic Esophageal Squamous Cell Carcinoma

NCT06487702 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-07-05

No results posted yet for this study

Summary

This is a prospective, single-arm, open-label，multi-center, phase Ib/II study, aiming to evaluate the efficacy and safety of Fruquintinib combined With Cadonilimab (AK104) and Tegafur，Gimeracil and Oteracil Potassium in patients with locally advanced or metastatic esophageal squamous cell carcinoma after the failure of first-line treatments.

Conditions

Interventions

DRUG

fruquintinib++Candonilimab+ Tegafur，Gimeracil and Oteracil Potassium

Fruquintinib administration for 2 weeks followed by 1-week break Candonilimab：10 mg/kg，D1，Q3W； Tegafur，Gimeracil and Oteracil Potassium：30mg BID for body surface area \< 1.25 m2; 40mg BID for body surface area of 1.25-1.5 m2; and 50mg BID for body surface area \>1.5 m2; D1-14, q3w

Sponsors & Collaborators

  • Rui-hua Xu, MD, PhD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-06-10
Completion
2027-06-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06487702 on ClinicalTrials.gov