Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma

Chemotherapy Effect Clinical Trial

Official title: A Phase II, Multicenter, Open-Label, Randomized, Controlled Study to Assess Efficacy and Safety of Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Chinese Subjects With Metastatic Esophageal Squamous Cell Carcinoma.

Status Recruiting

Clinical Trial Summary

This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cetuximab Effect
• Chemotherapy Effect
• Esophageal Cancer, Squamous Cell
• Esophageal Neoplasms
• Neoplasms, Squamous Cell

• NCT number: NCT03126708
• Study type: Interventional
• Source: Peking University
• Contact: Zhihao Lu, MD
• Phone: 86-10-88196561
• Email: pppeirain@126.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 10, 2017
• Completion date: April 2020