drugset / Trial / NCT05865132

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

NCT05865132

Phase 2 Unknown 30 enrolled Aiping Zhou
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2023-04-06
Primary completion
2025-04
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 30 mg Oral
Subject Afatinib Small molecule 40 mg Oral
Subject Palbociclib Small molecule 100 mg Oral
Subject Palbociclib Small molecule 125 mg Oral