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

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

NCT ID: NCT05865132

Condition: Esophagus Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Palbociclib
Afatinib

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Palbociclib
Description: 120mg/125mg po qd on day 1 to 21, every 28 days
Arm group label: Palbociclib + Afatinib

Intervention type: Drug
Intervention name: Afatinib
Description: 30mg/40mg po qd on day 1 to 28, every 28 days
Arm group label: Palbociclib + Afatinib

Summary: This is a prospective, multicenter, exploratory study. Patients with advanced esophageal or gastro-esophageal junction squamous carcinoma who had progressed on first-line chemotherapy combined with immune checkpoint inhibitors were treated with CDK4/6 inhibitor Palbociclib combined with Afatinib. Dose titration was used to determine the final dose, and objective antitumor efficacy was evaluated every 2 cycles (8 weeks +/- 7 days) according to RECIST 1.1 criteria, until tumor progression, intolerable toxicity, death, or withdrawal of informed consent. The primary endpoint is the objective response rate (ORR).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Aiping Zhou, MD

Phone: 86-10-87788800
Email: zhouap1825@126.com

Start date: April 6, 2023

Completion date: April 2026

Lead sponsor:
Agency: AIPING ZHOU
Agency class: Other

Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05865132