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

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.

Timeline

Start

2018-12-24

Primary completion

2022-12-31

Completion

2022-12-31

Publications

• Yang MH, Wu SY, Ho IW, Chiang NJ, Hsaio CF, Lin CY, Lien MY, Chang PM, Chen JH, Hsieh CY, Hong RL, Lee CT, Chen LT, Liu TW, Chiu CF, Bai LY. Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial. Cancer Med. 2025 Oct;14(20):e71307. doi: 10.1002/cam4.71307.

Drugs

Indications