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

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.

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.

• 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.