Actively Recruiting
A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
Led by West China Hospital · Updated on 2025-12-03
45
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically or cytologically confirmed esophageal squamous cell carcinoma that is locally advanced, unresectable, or has local recurrence or distant metastases
- EGFR overexpression or amplification confirmed by immunohistochemistry, FISH, or next generation sequencing (required in Phase 2)
- Disease progression after first-line or subsequent therapies
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate organ function within 7 days prior to treatment including hemoglobin 6 90 g/L, neutrophil count 6 1.5 �d7 10�b9/L, platelet count 6 75 �d7 10�b9/L
- Liver function within specified limits (bilirubin 4 1.5 �d7 upper limit of normal, ALT and AST 4 2.5 �d7 ULN or 4 5 �d7 ULN if liver metastases present)
- Kidney function with creatinine 4 1.5 �d7 ULN or creatinine clearance 70 mL/min
- Cardiac function with left ventricular ejection fraction 6 50%
- Coagulation parameters within normal limits (INR or PT 4 1.5 �d7 ULN)
- Female patients of childbearing potential must use contraception and have a negative pregnancy test before treatment
- Male patients must use contraception or have surgical sterilization during the study and for 8 weeks after
- Voluntary informed consent and willingness to comply with study and follow-up requirements
You will not qualify if you...
- History of other cancers in the past 5 years except cured basal cell carcinoma or cervical carcinoma in situ
- Active or past autoimmune disease
- Severe allergic reactions or known allergies to Afatinib, Palbociclib, or their components causing hospitalization
- Contraindications to Afatinib or Palbociclib
- Prior use of EGFR inhibitors or CDK4/6 inhibitors
- Live vaccines within 4 weeks before treatment or during the study
- Major surgery or significant trauma within 4 weeks before treatment
- Unresolved toxicities from previous anti-tumor therapy above Grade 1 except alopecia or neuropathy
- Severe medical conditions including heart failure NYHA Class II or higher, ischemic heart disease, serious arrhythmias, poorly controlled diabetes or hypertension, reduced heart function (LVEF < 50%), prolonged QTc interval, or abnormal ECG
- Active infections or fever within 48 hours before treatment or recent systemic antibiotics
- Active hepatitis B or C, HIV infection, or AIDS
- Pregnancy or breastfeeding
- Recent use of investigational drugs or concurrent enrollment in other clinical trials except observational or follow-up studies
- Any other condition that may interfere with study participation or completion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
J
Jin Zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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