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

• Status: Unknown status
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University
• Treatments: Cetuximab; Paclitaxel

Criteria

• Inclusion Criteria:

• Signed written informed consent.

• Older than 18 years of age.

• Histologically proven squamous cell carcinoma of the esophagus.

• Metastatic ESCC, not suitable for local-regional treatment.

• Presence of at least 1 measurable lesion according to RECIST version 1.1.

• ECOG performance status of 0 or 1.

• Adequate bone marrow, haptic, renal, metabolic function.

• Exclusion Criteria:

• Prior chemotherapy in the metastasis setting.

• Prior chemotherapy within 6 months before entering this study.

• Previous exposure to EGFR-targeted therapy.

• Known central nervous system metastasis and/or leptomeningeal disease.

• Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.