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.
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D
Beijing Cancer Hospital, Beijing, China
Beijing, China
RECRUITINGFirst Hospital of Xiamen University Affiliated Hospital,Xiamen,China
Xiamen, China
NOT_YET_RECRUITINGXinxiang Central Hospital of Henan Province, Xinxiang, China
Xinxiang, China
NOT_YET_RECRUITINGProgression-free survival
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.
Time frame: 2 years
Objective response rate
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Time frame: 2 years
Disease control rate
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Time frame: 2 years
Overall survival
OS is defined as the time from the first dose to the date of death due to any cause.
Time frame: 2 years
Adverse Events
Incidence and severity of adverse events.
Time frame: 2 years
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