drugset / Trial / NCT05865132
Palbociclib Combined With Afatinib for Advanced Squamous Carcinoma of Esophagus or Gastroesophageal Junction
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |