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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
simmitinib
Drugsimmitinib 6mg,QD ,3 weeks on 1 week off
investigator's choice of chemotherapy,include docetaxel or irinotecan.
Drugdocetaxel injection 75mg/m\^2,d1,every 3 weeks or ilinotecan injection 180mg/m\^2,d1,every 2 weeks
Treatment groups
Trial outcomes
Primary outcomes
OS
Secondary outcomes
ORR
Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1
PFS
Progression-free Survival
DCR
Disease Control Rate
DOR
Duration of Objective Response
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: