esophageal squamous cell cancer
Conditions
Interventions
Experimental group:Immunotherapy combined with radiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically diagnosed patients with advanced esophageal cancer, who have received systemic chemotherapy for stage IV esophageal cancer in the past, and are scheduled to receive immune monotherapy in the later line. 2. There are at least two measurable lesions (RECIST v1.1), and one of the lesions is less than 3cm in diameter and the total volume is less than 100cm^3 (small lesions); the maximum volume of large lesions is =3.5x10^9/L,: neutrophil (ANC) >=1.5x10^9/L, platelet (PLT) >=100x10^9/L, hemoglobin (HGB) >= 9g/dL; No severe pulmonary ventilation dysfunction and no acute heart failure as assessed by a radiotherapy physician. (2) Liver function: Serum total bilirubin (TBIL) = 2.8 g/dL. (3) Renal function: Serum creatinine =50 ml/min (calculated by Cockcroft/Gault formula): Female: CrCl=(140-years) x body weight (kg) x 0.85/ 72 x serum creatinine (mg/dL) Male: CrCl=(140-years) x body weight (kg) x 1.00 /72 x serum creatinine (mg/dL). 6. Sign the written informed consent, and be able to comply with the visits and related procedures stipulated in the program. 7. Expected survival > 3 months. 8. Patients who have no contraindications to radiotherapy are judged by the radiotherapy physician. 9. Patients who agree to receive immunotherapy and radiotherapy.
Exclusion criteria
Exclusion criteria: 1. Received PD-1, PD-L1 or PD-L2 treatment or other tumor immunotherapy; 2. There are pleural and pericardial effusions that are not clinically controlled and require repeated drainage or medical intervention; 3. There are indications of severe malnutrition; 4. The patient has a history of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease; 5. Severe heart function, liver function, renal insufficiency; 6. The use of immunosuppressive drugs within 4 weeks before the first dose of study treatment, excluding local glucocorticoids or physiological doses of systemic glucocorticoids by nasal spray, inhalation or other routes (i.e. no more than 10 mg/day of prednisone or equivalent doses of other glucocorticoids); 7. Systemic antibiotic treatment was used within 2 weeks before the first dose of the study, excluding the use of topical antibiotics; 8. Known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis, etc. (Vitiligo or complete remission of asthma in childhood without any intervention in adulthood can be enrolled; patients with type 1 diabetes mellitus with good insulin control can also be enrolled); 9. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 10. Suffering from other uncontrolled serious diseases, including but not limited to: (1) Serious infection in active stage or poorly controlled clinically; (2) HIV-infected patients (HIV antibody positive); (3) Acute or chronic active hepatitis B (HBsAg positive and HBV DNA>1*10^3/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA > 15IU/ml); (4) Active pulmonary tuberculosis, etc.; (5) Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmias; (6) Uncontrolled arterial hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg); (7) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, has occurred within 6 months before inclusion; (8) Diseases requiring anticoagulation with Farwarin (Coumarin); (9) Uncontrolled hypercalcemia (calcium ion greater than 1.5 mmol/L or calcium greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progress free survival;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;overall survival; | — |
Countries
China
Contacts
Public ContactLiu Yongmei
West China Hospital, Sichuan University
Outcome results
None listed