esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:None
Sponsors
He'nan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients with histologically confirmed metastatic esophageal squamous cell carcinoma who are not suitable for local treatment (radiotherapy or surgery); 2.Aged 18 to 75 years, regardless of gender; 3.Expected survival time >= 12 weeks; 4.According to the Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1), there is at least 1 measurable or evaluable lesion; 5.According to the Eastern Cooperative Oncology Group physical status score (ECOG PS score) is 0-2 points; 6.Having adequate organ and bone marrow function, as defined below: (1)Blood routine: absolute neutrophil count >=1.5x10^9/L; platelet count >=100x10^9/L; hemoglobin content >=9.0 g/dL; (2)Liver function: serum total bilirubin (TBIL) = 50 mL/min; urine dipstick test results show urine protein <2+; (4)Coagulation function: activated partial thromboplastin time (APTT) and international normalized ratio (INR) <= 1.5xULN.
Exclusion criteria
Exclusion criteria: 1.Pregnant, lactating women, women of childbearing age and their spouses refuse to take effective contraceptive methods; 2.Received systemic treatment for advanced or metastatic esophageal cancer in the past; 3.The following therapies have been received in the past: anti-PD-1, anti-PD-L1 drugs, or drugs that target another stimulation or synergistic inhibition of T cell receptors (eg, CTLA-4, OX-40, CD137); 4.Patients who are known to be allergic to the active ingredients or excipients of the study drug sintilimab, cisplatin, nedaplatin, albumin paclitaxel; 5.Patients with a high risk of bleeding or perforation due to the obvious invasion of the aorta or trachea by the tumor, or patients with fistula formation need to be excluded; 6.Past and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, drug-related pneumonia, severely impaired lung function and other pulmonary diseases; 7.Receive live attenuated vaccines within 4 weeks before enrollment or plan to receive live attenuated vaccines during the study; 8.Active, known or suspected autoimmune disease; 9.Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 10.Untreated acute or chronic active hepatitis B or C infection. For patients receiving antiviral therapy, under the condition of monitoring the number of virus copies, the doctor will judge whether they are eligible for inclusion according to the individual situation of the patient; 11.Uncontrolled concurrent diseases include but are not limited to: (1)HIV-infected persons (HIV antibody positive); (2)Serious infection in active stage or poorly controlled clinically; (3)The presence of severe or uncontrolled systemic disease (such as severe mental, neurological, epilepsy or dementia, unstable or uncompensated respiratory, cardiovascular, hepatic or renal disease, uncontrolled hypertension [i.e. Refers to evidence of greater than or equal to CTCAE grade 2 hypertension after drug treatment]); (4)Patients with active bleeding or new thrombotic disease who are taking therapeutic doses of anticoagulant drugs or have bleeding tendency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival;overall survival; | — |
Countries
China
Contacts
Public ContactWang Chaojie
He'nan Provincial People's Hospital
Outcome results
None listed