NCT06753747

A Trial of the Combination of Afatinib and Palbociclib in Previously Treated Advanced Esophageal Squamous Cell Carcinoma

A Phase 1b/2 Trial of Afatinib Plus Palbociclib in Previously Treated Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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. The main questions it aims to answer are: What is the safe and tolerable dose of Afatinib when combined with 100 mg of Palbociclib (administered orally, three weeks on and one week off)? Does the combination therapy of Afatinib and Palbociclib induce a tumor response in patients with recurrent or metastatic esophageal squamous cell carcinoma who have received prior treatments?

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib	Palbociclib will be given at a dose of 100 mg every day orally with three weeks on and one week off. Four weeks is a cycle.
DRUG	Afatinib(30mg)	Afatinib will be administered orally at a dose of 30 mg once daily (QD) in each 4-week cycle.
DRUG	Afatinib(40mg)	Afatinib will be administered orally at a dose of 40 mg once daily (QD) in each 4-week cycle.
DRUG	Afatinib(RP2D)	In the Phase 2 study, the recommended Phase 2 dose (RP2D) of Afatinib, determined during the Phase 1b portion, will be utilized.

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2024-12-31
• Last updated: 2025-12-03

Locations

1 site across 1 country: China