OncoMatch/Clinical Trials/NCT06753747
A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
Is NCT06753747 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Palbociclib and Afatinib(30mg) for esophagus cancer.
Treatment: Palbociclib · Afatinib(30mg) · Afatinib(40mg) · Afatinib(RP2D) — The goal of this clinical trial is to learn if Afatinib plus Palbociclib works in previously treated recurrent or metastatic esophageal squamous cell carcinoma. It will also learn about the safety of the combination of Afatinib and Palbociclib. The main questions it aims to answer are: What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)? Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: EGFR overexpression (IHC 3+)
Immunohistochemistry confirmed EGFR(3+)...only patients with EGFR overexpression will be included in Phase 2
Required: EGFR amplification
EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-tumor therapy — first-line or subsequent lines
Disease progression after first-line or subsequent lines of therapy.
Cannot have received: EGFR inhibitor
Prior use of EGFR inhibitors
Cannot have received: CDK4/6 inhibitor
Prior use of...CDK4/6 inhibitors
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 × 10⁹/L; Platelet count ≥ 75 × 10⁹/L
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min
Liver function
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN with liver metastases)
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% by Doppler ultrasound
Adequate organ function within 7 days prior to treatment initiation, meeting the following criteria: Hematology (without transfusion, blood products, or administration of G-CSF or other hematopoietic stimulants within the past 14 days): Hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 75 × 10⁹/L. Serum biochemistry: Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN; Serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 60 mL/min. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%, as assessed by Doppler ultrasound. Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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