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

Peking University

Status and phase

Unknown

Phase 2

Conditions

Chemotherapy Effect

Esophageal Cancer, Squamous Cell

Cetuximab Effect

Treatments

Drug: cisplatin plus paclitaxel

Drug: cetuximab

Study type

Interventional

Funder types

Other

Identifiers

NCT03126708

ESCC-Cetuximab-PKU

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.