To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC

Sponsor
Peking University
Study ID
NCT05818982
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Afatinib — DRUG
    Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
  • Irinotecan — DRUG
    Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D

Study Details

This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.

Key Dates

Start date
Feb 9, 2023
Status verified
Apr 2023
Primary completion
Feb 28, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Group A received afatinib (40 mg oral/day) every 6 weeks
  • Active Comparator: Cohort B
    Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks

Primary Outcome Measure

Progression-free survival [ Time Frame: 2 years ]

Central Contacts

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