Overview

Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy

Status:
Active, not recruiting

Trial end date:
2022-12-31

Target enrollment:

Participant gender:

Summary

This is an open-label, single arm, multicenter phase 2 study. The study is to evaluate the activity of a combination therapy with nal-IRI (PEP02, MM-398, Onivyde®) plus 5-FU and leucovorin in patients with squamous cell carcinoma of head & neck and esophagus failed to platinum-based treatment in prior chemotherapy or chemoradiotherapy. The primary endpoint is to assess the objective tumor response rate (ORR). Eligible patients will be enrolled to receive combination therapy of nal-IRI plus 5-FU and Leucovorin on day 1, every 2 weeks. Every 2 weeks will be counted as one cycle. Treatment will continue until disease progression, unacceptable toxicity or other condition meeting the discontinuation criteria.

Phase:

Phase 2

Details

Lead Sponsor:

National Health Research Institutes, Taiwan

Collaborators:

China Medical University Hospital
National Cheng-Kung University Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital

Treatments:

Camptothecin
Irinotecan