Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction

Launched by AIPING ZHOU · May 17, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of two medications, Palbociclib and Afatinib, to treat patients with advanced squamous cell carcinoma of the esophagus or gastroesophageal junction. This study is specifically for patients who have not responded well to previous treatments that included chemotherapy and immune checkpoint inhibitors. The goal is to see how effective this combination of drugs is in shrinking tumors. Participants will be monitored regularly, and their treatment will be adjusted based on how well they respond and any side effects they experience.

To be eligible for this trial, participants must be between 18 and 75 years old and have a confirmed diagnosis of advanced or inoperable squamous cell carcinoma that is not treatable with standard radiation. They should have already undergone at least one round of chemotherapy that included immune checkpoint inhibitors. Additionally, they need to have good overall health and organ function, which will be assessed through various medical tests. If you or someone you know is interested in this trial, it’s important to discuss it with a healthcare provider to determine if it’s a suitable option. The trial is currently recruiting participants, and those who join can expect close monitoring of their health and treatment progress.

Gender

ALL

Eligibility 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