Advanced esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Radiation therapy is started on day 1 at 2 Gy once a day until the target dose reaches 10 Gy per 5 doses. On the 6th day after the start of radiotherapy, docetaxel + PD1 inhibitor w
observe group:The control group was treated with docetaxel at the recommended dose according to the instructions, intravenous infusion, and Q3W treatment until the disease progressed.
Sponsors
Sichuan Mianyang 404 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. All subjects are required to sign an informed consent form before starting the study-related operations; and be able to comply with the visits and related procedures specified in the program; 2. Male or female>= 18 years old; 3. Cytological or histological diagnosis of esophageal squamous cell carcinoma, which is not resectable and is locally advanced or metastatic esophageal squamous cell carcinoma; 4. Agree to provide tumor tissue specimens, either previously archived or freshly obtained, for biomarker testing; 5. Subjects who have previously received first-line therapy failure; 6. At least one measurable lesion (RECIST v1.1 criteria), for a lesion that has received prior radiotherapy, it can only be considered as a target lesion if there is clear disease progression after radiotherapy; 7. ECOG score 0-1; 8. Estimated survival > 3 months; 9. The function of vital organs and bone marrow meets the following requirements.9.1 Complete blood count:White blood cell count >= 3.5×10^9/L, neutrophil (ANC) >= 1.5 ×10^9/L, platelet (PLT) >= 90×10^9/L, hemoglobin (HGB) >=9g/dL;9.2 Liver function:serum total bilirubin (TBIL) =50 ml/min (calculated using the Cockcroft/Gault formula);Females: CrCl = (140-years) x body weight (kg) x 0.85,72 x serum creatinine (mg/dL).Male: CrCl = (140 - years) x weight (kg) x 1.00,72 serum creatinine (mg/dL);9.4 Coagulation:1.INR=50 percent;QTcF interval <= 450 ms 10. Normal thyroid function; 11. Toxic side effects (except for hair loss, etc.) from previous treatment <= grade 1 or return to baseline level; 12. The investigator judged that the compliance was good, and the prescribed visits, treatments and laboratory examinations could be completed according to the study protocol; 13. For female subjects of childbearing age, pregnancy was excluded.
Exclusion criteria
Exclusion criteria: 1. Participants with active central nervous system (CNS) metastases (including but not limited to carcinomatous meningitis and spinal cord compression) were excluded.; 2. With tumor emergency, need immediate treatment; 3. Subjects with peripheral neuropathy; 4.The investigators considered significant coagulation abnormalities or were receiving thrombolytic or anticoagulant therapy; 5. Subjects required systemic treatment with corticosteroid (10 mg of prednisone daily) or other immunomodulatory agents (interleukin-2, interferon-alpha, interferon-gamma, cyclosporine, G-CSF, mTOR inhibitor) for 28 days prior to study treatment; 6. Heart disease or impairment of cardiac function of clinical significance:•Clinically significant cardiac disease, such as CHF requiring treatment or uncontrolled arterial hypertension, defined as blood pressure > 140/100 mmHg at rest (average of 3 consecutive measurements); •History of clinically significant arrhythmias, atrial fibrillation, and/or conduction abnormalities (1*103/ml, DNA>200IU/ml) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA >). 15IU/ml); - Active tuberculosis, etc.; - Class III-IV congestive heart failure (New York Heart Association classification), poorly controlled and clinically significant arrhythmia; -Uncontrolled arterial hypertension (systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg); -Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, etc., within 6 months prior to the selected treatment; -Diseases requiring anticoagulation with warphallin (coumarin); -Uncontrolled hypercalcemia (greater than 1.5 mmol/L of calcium or greater than 12 mg/dL or corrected serum calcium greater than ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy; 13.A pregnant or lactating woman. 14.Other malignant tumors occurred within 5 years before the first dose. 15.Known mental illness, alcoholism, drug use or substance abuse. 16.Subjects who had received or planned to receive the live vaccine within 4 weeks before the first study drug were enrolled. 17. Other acute or chronic diseas
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS,Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of relief;Overall survival; | — |
Countries
China
Contacts
Public ContactSu Zhou
Sichuan Mianyang 404 Hospital
Outcome results
None listed