Esophageal squamous cell carcinoma
Conditions
Interventions
Treacilil plus immunotherapy plus chemotherapy:Treacilil, 240mg/m2, d1, same cycle number as chemotherapy
Immunotherapy (=35 cycles) :
Carrilizumab, 200mg, d1
Or triplimumab, 240mg, d1
Or Sindilizumab, 3mg/kg (body weight < 60kg), 200mg (body weight =60kg), d1
Or Tirellizumab, 200mg, d1
Chemotherapy (=6 cycles) :
Paclitaxel, 175mg/m2, d1
Carboplatin, AUC=4-6, d1(YNMT)·
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Age 18-75 years old, male or female; 3. Histologically/pathologically diagnosed as unresectable metastatic/recurrent esophageal squamous cell carcinoma; 4. Have =1 measurable lesion (according to RECIST 1.1 criteria); 5. Have not received any anti-tumor systemic therapy, including but not limited to immunotherapy, targeted therapy, chemotherapy, etc.; 6. Patients with asymptomatic BMS or BMS whose symptoms are stable after treatment; 7.ECOG score: 0 ~ 1; 8. Adequate organ function: (1) Blood routine: WBC=3.0×10^9/L; ANC=1.5×10^9/L; PLT=100×10^9/L; HGB=90 g/L; (2) Liver function: AST=2.5×ULN or =5×ULN (for patients with liver metastasis); ALT=2.5×ULN or =5×ULN (for patients with liver metastasis); TBIL=1.5×ULN; (3) Renal function: Cr=1.5×ULN or CrCl =60 mL/min; (4) Coagulation function: INR=1.5, APTT=1.5×ULN; (5) No obvious abnormality in electrocardiogram; 9. Estimated survival =3 months; 10.There was no fertility or lactation plan during the treatment period and 6 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1.The subject has a history or concurrent history of other malignant tumors; 2.Patients with the following diseases: known HIV infection, active hepatitis B (defined as HBV DNA positive) and hepatitis C (HCV RNA positive); Having interstitial lung disease/pulmonary inflammation; Active or suspected autoimmune disease requiring systemic treatment in the past 2 years; 3.Received attenuated live vaccine within 4 weeks prior to enrollment, or expected to receive attenuated live vaccine during the study period; 4.Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA grade III or IV); 5.Stroke or cardiovascular events within 6 months prior to enrollment; 6.When screening, the QTcF interval > 480msec, and for patients with implanted ventricular pacemakers, the QTcF interval > 500msec; 7.Previously received hematopoietic stem cell or bone marrow transplantation; 8.Allergy to the investigational drug or its components; 9.Other situations that the researcher deems unsuitable for participation in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade = 3 neutropenia during chemotherapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of grade = 3 thrombocytopenia during chemotherapy;Incidence of grade = 3 anemia during chemotherapy;Disease control rate;Progression free survival rate;safety; | — |
Countries
China
Contacts
Public ContactZhou Jin
Sichuan Cancer Hospital
Outcome results
None listed