Esophageal squamous cell carcinoma
Conditions
Interventions
Chemotherapy-immunotherapy sequential radiotherapy:Chemotherapy + PD-1/PD-L1 immunotherapy
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age: >=18 years old, male or female; 2. Histopathologically confirmed squamous oesophageal cancer; oesophageal cancer with primary clinical stage IVb (AJCC staging 8th edition) with oligometastasis to 3 organs = 3 months; 6. Patients with asymptomatic or locally stabilised brain metastases will be allowed to enrol if they meet the following criteria: 1) have a measurable lesion outside of the CNS 2) have no CNS symptoms or no exacerbation of symptoms for at least 2 months 3) do not require glucocorticosteroid treatment or have discontinued glucocorticosteroid treatment within 3 days prior to the first dose of study medication 7. Patients with normal function of major organs, without serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immunodeficiency. Laboratory tests meet the following requirements: Haemoglobin (Hb) >= 90 g/L; White blood cell (WBC) >= 3.0 x 109/L; Neutrophil count (NEUT) >= 1.5 x 109/L; Platelet (PLT) >= 100 x 109/L; Liver function (alanine aminotransferase AST or alanine aminotransferase ALT) <= 2.5 times the upper limit of the normal ( ULN); renal function (kidney function) <= 2.5 times the upper limit of normal ( ULN). ULN); renal function (serum creatinine sCr) level <= 1.5 times the upper limit of normal (ULN); total bilirubin (TBIL) <= 1.5 times the upper limit of normal (ULN); urinary protein, urinary occult blood <2+; faecal occult blood <2+. 8. Subjects voluntarily enrolled in the study, signed the informed consent, good compliance, and cooperate with the follow-up; 9. The investigator believes that the treatment can be beneficial.
Exclusion criteria
Exclusion criteria: 1. Unable to tolerate digestive endoscopy biopsy; 2. Having clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, positive fecal occult blood); 3. A history of gastrointestinal bleeding within 6 months; allergy or contraindication to the study drug; 4. Having uncontrollable active infections (such as sepsis, active tuberculosis, etc.); 5. Having a history of severe cardiovascular and cerebrovascular diseases, such as myocardial infarction (within the past 6 months), severe arrhythmia, heart failure (NYHA classification >= III), etc.; 6. Having a history of autoimmune diseases or receiving immunosuppressive therapy; 7. Being at risk of active gastrointestinal bleeding, perforation, or obstruction; 8. Pregnant or lactating women, or patients with fertility plans who have not taken effective contraceptive measures during the study and within 6 months after the end of the study; 9. Having other severe, uncontrollable diseases or mental disorders that may affect the patient's participation in the study or evaluation; 10. Patients deemed inappropriate for inclusion in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective response rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactChunbao Zang
Anhui Provincial Cancer Hospital
Outcome results
None listed