OncoMatch/Clinical Trials/NCT05865132
Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction
Is NCT05865132 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Palbociclib and Afatinib for esophagus squamous cell carcinoma.
Treatment: Palbociclib · Afatinib — 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).
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy — first-line
Prior progression to at least first-line chemotherapy
Must have received: checkpoint inhibitor — first-line
which must include immune checkpoint inhibitors (except in patients with contraindications to immune checkpoint inhibitors)
Cannot have received: CDK4/6 inhibitor
Have received CDK4/6 inhibitors
Cannot have received: EGFR tyrosine kinase inhibitor
Have received...anti-EGFR targeted drugs in the past
Lab requirements
Blood counts
hemoglobin ≥90 g/L, neutrophil ≥1.5×10^9/L, platelet ≥100×10^9/L
Kidney function
creatinine ≤1.5× upper limit of normal (UNL) or creatinine clearance ≥50 ml/min
Liver function
total bilirubin (TBIL) ≤1.5× upper limit of normal (UNL); ALT ≤2.5× UNL, AST ≤2.5× UNL
Cardiac function
Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
Blood routine: hemoglobin ≥90g/L, neutrophil ≥1.5×10^9/L, platelet ≥100×10^9/L; Renal function: creatinine≤1.5×upper limit of normal (UNL) or creatinine clearance ≥50ml/min; Liver function: total bilirubin (TBIL)≤1.5×upper limit of normal (UNL); ALT≤2.5×UNL, AST≤2.5×UNL; Ejection fraction at least 50% (or lower limit of normal) by echocardiogram
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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