??Esophageal Squamous Cell Carcinoma
Conditions
Interventions
Experimental group:Low-dose Chemotherapy Combined with Immunotherapy, Further Combined with Concurrent Chemoradiotherapy or Surgery
Sponsors
Chinese People's Liberation Army (PLA) General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Patients voluntarily participate in this research project, demonstrate good compliance, can cooperate with the trial requirements to complete observation and follow-up, and sign the informed consent form; 2.Diagnosed with esophageal squamous cell carcinoma (ESCC) by histopathological examination, with clinical stage T2-4bN0-3M0-1 (M1 includes only supraclavicular lymph node metastasis); no anti-tumor drug treatment other than the trial drug has been received within the previous 4 weeks, and the patient is eligible to receive specialized anti-tumor treatment; 3.ECOG performance status = 3,000/µL, absolute neutrophil count (ANC) >= 1,500/µL, platelet count >= 100,000/µL, hemoglobin (Hb) >= 9.0 g/dL; Aspartate transaminase (AST) and alanine transaminase (ALT) = 60% as assessed by Doppler ultrasound; 7.Female patients: Use effective contraception during treatment and within 6 months after the end of treatment; non-lactating; Male patients: Use effective contraception during treatment and within 6 months after the end of treatment.
Exclusion criteria
Exclusion criteria: 1.Female patients who are pregnant, lactating, or of childbearing potential without effective contraceptive measures; 2.Patients with existing severe acute infections, suppurative or chronic infections, or those with poorly healing wounds; 3.Patients who have received other anti-tumor treatments within 4 weeks before enrollment; 4.Patients with abnormal coagulation function, bleeding tendency (such as active peptic ulcer), or those currently receiving thrombolytic or anticoagulant therapy; 5.Patients with pre-existing severe heart diseases, including: congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe valvular heart disease, and refractory hypertension; 6.Patients with poorly controlled neurological or psychiatric diseases/disorders, poor compliance, and inability to cooperate with the study or describe treatment responses; 7.Patients with severe liver cirrhosis or severe renal insufficiency; 8. Previously received treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival;Adverse Event; | — |
Countries
China
Contacts
Public ContactLiu Fang
Chinese People's Liberation Army (PLA) General Hospital
Outcome results
None listed