RecruitingPhase 2NCT05865132

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

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


Sponsor

AIPING ZHOU

Enrollment

30 participants

Start Date

Apr 6, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests the combination of palbociclib and afatinib — two targeted therapy drugs — in people with advanced squamous cell carcinoma of the esophagus or gastroesophageal junction that has progressed after prior treatment. **You may be eligible if...** - You have been diagnosed with advanced or inoperable squamous cell carcinoma of the esophagus or the junction where the esophagus meets the stomach - Your cancer has progressed after at least one prior chemotherapy regimen, including immunotherapy if not contraindicated - You are between 18 and 75 years old - You are in good general health (ECOG 0–1) with adequate organ function - You have at least one measurable tumor **You may NOT be eligible if...** - Your cancer is a different type (adenocarcinoma or mixed) - You have previously received CDK4/6 inhibitors or anti-EGFR drugs - You have a known allergy to the study drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

120mg/125mg po qd on day 1 to 21, every 28 days

DRUGAfatinib

30mg/40mg po qd on day 1 to 28, every 28 days


Locations(1)

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

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05865132


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