A Study of Simmitinib Versus Chemotherapy for Participants With Advanced Oesophageal Squamous Cell Carcinoma

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Runshi Pharmaceutical Technology Co., Ltd

About this trial

To evaluate the overall survival of simmitinib versus investigator's choice of chemotherapy for Participants with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression after first-line standard therapy.

Eligibility criteria

Qualifiers

Absolute Neutrophil count (ANC) ≥ 1.5 × 10^9/L;

Platelet count (PLT) ≥ 100× 10^9/L;

Hemoglobin (Hb) ≥ 90 g/L;

Serum creatinine ≤ 1.5 × ULN and Creatinine clearance (CCr)≥60mL/min(According to the Cockcroft-Gault formula);

Disqualifiers

1. Patients who have previously received any anti-tumor therapy within 4 weeks prior to randomization; 2. Patients who have previously received major surgical treatment、open biopsy、other clinical trial drug treatment or any live attenuated vaccine within 4 weeks prior to randomization, or are expected to received any live attenuated vaccine during the study.

Trial design

Treatments tested in this trial

  • simmitinib
  • investigator's choice of chemotherapy,include docetaxel or irinotecan.

Treatment groups

450 Participants
are divided into 2 treatment groups

Locations

This trial has no locations