esophageal squamous cell carcinoma
Conditions
Interventions
Exposed group:None
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Histopathologically confirmed esophageal squamous cell carcinoma; 2.Received albumin paclitaxel, platinum, and PD-1 monoclonal antibody regimen treatment. And no previous anti-tumor treatments such as chemotherapy, radiation therapy, molecular targeted therapy, immunotherapy, biological therapy, or traditional Chinese medicine in 4 weeks before enrollment; 3.Imaging (CT or MR) or endoscopic ultrasound examination staging, AJCC 8th edition, is T3-4aN0M0, T1-4aN+M0, or any T any N M1. 4.Blood and tissue samples are available for this study; 5.ECOG PS score is 0-1; 6.All major organ functions are normal; 7.Cardiac function is basically normal, left ventricular ejection fraction >= 50%, and blood pressure was controlled within 140/90 mmHg before enrollment. 8.Pulmonary function is basically normal, without moderate to severe obstructive or diffuse dysfunction; 9.Voluntarily sign (or sign by legal representative) "the Informed Consent Form for Scientific Research on Patient Samples" of Beijing Cancer Hospital, to prove their consent for researchers to collect medical records, tissue samples, and blood samples for subsequent scientific research; 10.Age: 18-75 years old, gender not limited.
Exclusion criteria
Exclusion criteria: 1.Pathological type is not squamous cell carcinoma such as adenocarcinoma and small cell carcinoma of esophagus; 2.Imaging (CT or MRI) and endoscopic ultrasound examination suggest early stage esophageal cancer, including carcinoma in situ (Tis), lesions only invading the mucosal layer or intrinsic muscle layer without lymph node metastasis (T1-2N0); 3.Within 4 weeks prior to receiving albumin paclitaxel, platinum, and PD-1 monoclonal antibody regimens treatment, imaging (esophagography, CT or MR) examinations suggest the presence of esophageal mediastinal fistula or esophagotracheal fistula,or patient had obvious gastrointestinal bleeding such as vomiting blood and black stools; 4.Unable to obtain blood and tissue samples for this study; 5.Received treatment which regimen without albumin paclitaxel, platinum, and PD-1 monoclonal antibody regimen. Or received other anti-tumor treatment such as chemotherapy, radiotherapy, targeting treatment, traditional Chinese medicine within 4 weeks prior to enrollment. Or vaccinated, undergone surgery, or suffered serious injuries within 4 weeks prior to enrollment; 6.With active autoimmune diseases, suffering from other acquired or congenital immunodeficiency diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism etc.), history of immunodeficiency (including positive HIV testing), history of organ or bone marrow transplantation, or those who not eligible of received PD-1 immunotherapy by researchers; 7.Having uncontrolled cardiovascular symptoms or diseases, including but not limited to: NYHA grade II or above heart failure, unstable angina pectoris, experienced myocardial infarction within one year, serious supraventricular or ventricular arrhythmias that have not clinically intervention or still poorly controlled after clinical intervention; 8.With serious infections (CTC AE>grade 2) within 4 weeks before first dose of PD-1 monoclonal antibody, such as severe pneumonia, bacteremia, and infection complications that require hospitalization treatment. Or baseline chest imaging examination suggests active pulmonary inflammation, signs of infection within 2 weeks before the first dose of treatment. Or infection that require for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics; 9.Pregnant or lactating women; 10.With other factors that may affect the accuracy of tissue specimen testing results and clinical data collection. For example: suffering from serious illnesses including mental illness that require concurrent treatment; with significant abnormalities in laboratory test values; other family or social factors that may affect subjects’ safety or data collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, median progression-free survival, median overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactJia Jun
Beijing Cancer Hospital
Outcome results
None listed