This is a prospective, multicenter, exploratory study. Patients with advanced esophageal or gastro-esophageal junction squamous carcinoma who had progressed on first-line chemotherapy combined with immune checkpoint inhibitors were treated with CDK4/6 inhibitor Palbociclib combined with Afatinib. Dose titration was used to determine the final dose, and objective antitumor efficacy was evaluated every 2 cycles (8 weeks +/- 7 days) according to RECIST 1.1 criteria, until tumor progression, intolerable toxicity, death, or withdrawal of informed consent. The primary endpoint is the objective response rate (ORR).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
120mg/125mg po qd on day 1 to 21, every 28 days
30mg/40mg po qd on day 1 to 28, every 28 days
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGORR
objective response rate
Time frame: 3 years
DCR
disease control rate
Time frame: 3 years
PFS
progression free survival
Time frame: From date of initiation of treatment to date of progression or death due to any cause, whichever occurs first up to 3 years
OS
overall survival
Time frame: From date of initiation of treatment to date of death up to 3 years
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