NCT05865132

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: AIPING ZHOU · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Esophagus Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Palbociclib	120mg/125mg po qd on day 1 to 21, every 28 days
DRUG	Afatinib	30mg/40mg po qd on day 1 to 28, every 28 days

Timeline

• Start date: 2023-04-06
• Primary completion: 2025-04-01
• Completion: 2026-04-01
• First posted: 2023-05-18
• Last updated: 2023-05-18

Locations

1 site across 1 country: China