Overview

An Open-label, Single-arm, Interventional Clinical Study to Evaluate the Efficacy of Afatinib in Skull Base Chordom

Status:
Not yet recruiting

Trial end date:
2025-12-30

Target enrollment:

Participant gender:

Summary

This is a single arm, open label, single center, and prospective, interventional study to explore clinical efficacy of afatinib in patients with chordoma of skull base. Subject meeting the inclusion criteria will take afatinib (40 mg daily) orally, 4 weeks for a cycle. The primary objective is to assess the efficacy of afatinib in chordoma of skull base by objective response rate (ORR). The Secondary objectives is to assess progression free survival (PFS), overall survival (OS), tumor response duration and tumor shrinkage degree in patients with chordoma of skull base after using afatinib; to evaluate the safety and tolerability of afatinib in patients with chordoma of skull base.

Phase:

Phase 2

Details

Lead Sponsor:

Huashan Hospital

Collaborator:

Boehringer Ingelheim

Treatments:

Afatinib