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New treatment option for Esophagus Cancer
Official title A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06753747
What this study is testing
What is Palbociclib?
Palbociclib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for esophagus cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 and 75 years
- Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant...
- Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification (EGFR expression is not...
- Disease progression after first-line or subsequent lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
You likely can't join if
- Patients who have a history of other malignancies in the past five years (except for the cured basal cell carcinoma and cervical carcinoma in situ)
- The patient has any active autoimmune disease or a history of autoimmune disease
- History of severe allergic reactions or known allergies to macromolecular protein preparations, Afatinib, Palbociclib, or any component of their...
- Presence of contraindications to Palbociclib or Afatinib.
- Previous or planned treatments as follows:
- Prior use of EGFR inhibitors or CDK4/6 inhibitors.
See the full eligibility criteria
- Age between 18 and 75 years
- Histologically or cytologically confirmed as ESCC, locally advanced and unresectable, with local recurrence (local lymph node metastases) or distant metastases
- Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification (EGFR expression is not required in Phase 1b, but only patients with EGFR overexpression will...
- Disease progression after first-line or subsequent lines of therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 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...
- 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 × the upper limit of normal (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...
- Female patients of childbearing potential must agree to use appropriate contraception from screening until 3 months after the end of treatment and must not be breastfeeding. A negative pregnancy test is required within...
- All people are recruited on a voluntary basis and sign the informed consent. They are required to be compliant with the study and cooperative with the follow-up.
- Patients who have a history of other malignancies in the past five years (except for the cured basal cell carcinoma and cervical carcinoma in situ)
- The patient has any active autoimmune disease or a history of autoimmune disease
- History of severe allergic reactions or known allergies to macromolecular protein preparations, Afatinib, Palbociclib, or any component of their formulations that have resulted in hospitalization.
- Presence of contraindications to Palbociclib or Afatinib.
- Previous or planned treatments as follows:
- Prior use of EGFR inhibitors or CDK4/6 inhibitors.
- Administration of any live vaccines (e.g., influenza or varicella vaccines) within 4 weeks before the first dose or during the study.
- Major surgery or significant trauma within 4 weeks before the first dose.
- Residual toxicities from prior anti-tumor therapies not resolved to ≤ Grade 1 per CTCAE v5.0, except for alopecia or platinum-based therapy-induced neuropathy.
- Severe medical conditions, such as:
- NYHA Class II or higher heart failure.
- Ischemic heart disease (e.g., myocardial infarction or angina).
- Clinically significant supraventricular or ventricular arrhythmias.
- Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol/L).
- Poorly controlled hypertension (systolic BP \> 150 mmHg and/or diastolic BP \> 100 mmHg).
- Left ventricular ejection fraction (LVEF) \< 50% on echocardiography.
- QTc interval \> 450 ms in males or \> 470 ms in females.
- Abnormal ECG findings deemed to pose additional risk by the investigator.
- Active infections or unexplained fever within 48 hours prior to the first dose, or systemic antibiotic use within one week prior to informed consent.
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL), hepatitis C (anti-HCV antibody positive with detectable HCV RNA), known HIV positivity, or acquired immunodeficiency syndrome (AIDS).
- Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.
- Pregnancy or lactation.
- Receipt of any investigational drug within 4 weeks before the first dose or concurrent enrollment in another clinical trial, except for observational (non-treatment) studies or treatment trials in follow-up.
- Any other factors deemed by the investigator to potentially interfere with study participation, including the ability to complete study treatment and follow-up.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.