Combining Palbociclib and Afatinib for Advanced Esophageal Cancer
CDK4/6 Inhibitor Palbociclib Combined With Afatinib as Second-line Treatment for Advanced Squamous Carcinoma of the Esophagus or Gastroesophageal Junction Progressed on at Least First-line Chemotherapy: a Phase 2 Trial
PHASE2 · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT05865132
This study is testing whether combining two cancer drugs, Palbociclib and Afatinib, can help people with advanced esophageal cancer who haven't responded to earlier treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other) |
| Drugs / interventions | chemotherapy, Afatinib |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05865132 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Palbociclib, a CDK4/6 inhibitor, in combination with Afatinib for patients with advanced squamous carcinoma of the esophagus or gastroesophageal junction who have previously progressed on first-line chemotherapy and immune checkpoint inhibitors. The study is multicenter and prospective, utilizing dose titration to determine the optimal dosage for participants. The primary endpoint is the objective response rate, evaluated every two cycles until disease progression or intolerable side effects occur.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with pathologically confirmed advanced squamous carcinoma of the esophagus or gastroesophageal junction who have progressed on prior chemotherapy including immune checkpoint inhibitors.
Not a fit: Patients with early-stage disease or those who have not received prior chemotherapy with immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new therapeutic option for patients with advanced esophageal cancer who have limited treatment choices.
How similar studies have performed: While this approach is exploratory, similar combinations of targeted therapies have shown promise in other cancer types, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed metastatic or inoperable locally advanced squamous carcinoma of the esophagus or gastroesophageal junction that is not amenable to radical radiotherapy. * Prior progression to at least first-line chemotherapy which must include immune checkpoint inhibitors (except in patients with contraindications to immune checkpoint inhibitors). Adjuvant/neoadjuvant therapy is allowed and is considered first-line therapy for advanced disease if recurrence occurs during or within 6 months of completion of adjuvant/neoadjuvant therapy. * At least one measurable tumor lesion according to RECIST V1.1 criteria. A lesion previously treated with radiotherapy is not acceptable as a target lesion unless the lesion is significantly progressive. * Sign the informed consent form * 18\~75 years * Performance status: ECOG 0-1 * Good organ function: 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 Exclusion Criteria: * Other pathological category, such as adenocarcinoma, adenosquamous carcinoma * Have received CDK4/6 inhibitors or anti-EGFR targeted drugs in the past * Known to have allergic reactions to any ingredients or excipients of experimental drugs * Unable to swallow or under other circumstance which would drug absorption * Other active malignant tumors, excluding those who have been disease free for more than 5 years or in situ cancer considered to have been cured by adequate treatment * Diabetes was not controlled, defined as HbA1c \> 7.5% after anti-diabetic drugs or hypertension was not controlled, defined as systolic / diastolic blood pressure \> 140 / 90 mmHg after antihypertensive drug * Myocardial infarction, severe/unstable angina, New York Heart Association (NYHA) class III or IV congestive heart failure in the past 12 months * Known to be infected with human immunodeficiency virus (HIV), have acquired immunodeficiency syndrome (AIDS) related diseases, have active hepatitis B or hepatitis C * Pregnant or nursing * May increase the risk associated with participation in the study or administration of the study drug or mental illness that may interfere with the interpretation of research results * There are other serious diseases that the researchers believe patients cannot be included in the study
Where this trial is running
Beijing, Beijing
- National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College — Beijing, Beijing, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Esophagus Squamous Cell Carcinoma