Esophageal cancer
Conditions
Interventions
Sponsors
Taizhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old, both male and female; 2. Histologically or cytologically confirmed diagnosis of esophageal cancer with locally advanced unresectable, locally recurrent (local lymphatic metastasis) or with distant metastasis; 3. patients who have received first-line systemic chemotherapy or chemotherapy combined with immunotherapy (chemotherapy regimen may include platinum-based, fluorouracil-based) for progression or intolerance (progression of maintenance therapy after first-line chemotherapy may also be included). Simultaneous radiotherapy received for postoperative recurrence or metastasis is counted as first-line treatment; 1.for radical simultaneous radiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or radiochemotherapy), if disease progression occurs during the resultant treatment or within 6 months after cessation of the treatment, it should be counted as a failure of first-line treatment; 4. have at least one measurable lesion according to the criteria for evaluating the efficacy of solid tumors (RECIST 1.1), and the measurable lesion should not have received localized treatment such as radiotherapy (lesions located in the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets the RECIST 1.1 criteria); 5. ECOG: 0 to 1; 6. expected survival >= 12 weeks; 7. Normal function of major organs, i.e. meeting the following criteria: (1) Routine blood tests: a. HB >= 90g/L b. ANC >= 1.5×10^9/L c. PLT >= 80×10^9/L; 2.(2) Biochemical examination: a. ALB >= 30g/L; 3.b. ALT and AST = 60ml/min; 8.. Females of childbearing potential should be patients who agree that contraception (e.g., IUD, birth control pills, or condoms) is mandatory during the study period and for 6 months after the end of the study; 7.have had a negative serum or urine pregnancy test within 7 days prior to study enrollment and must not be breastfeeding; 8.males should agree that contraception is mandatory during the study period and for 6 months after the end of the study period; 9. Subjects voluntarily enroll in the study, sign an informed consent form, are compliant, and cooperate with follow-up visits.
Exclusion criteria
Exclusion criteria: 1. The patient has any active autoimmune disease or a history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; 1.the patient has vitiligo; 2.the patient's asthma was in complete remission in childhood and does not require any intervention in adulthood; 3.the patient's asthma that requires medical intervention with a bronchodilator cannot be included. (the asthma of the patient cannot be included); 2. patients who are on immunosuppressive, or systemic hormone therapy for immunosuppression (dose >10 mg/day prednisone or other equipotent hormone) and continue to use it within 2 weeks prior to enrollment; 3. patients with esophageal squamous carcinoma whose primary lesion is active bleeding; 4. those with multiple factors affecting the oral administration of medications (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction, etc.) 5. patients with brain metastases accompanied by symptoms or symptom control for less than 3 months; 6. patients with any severe and/or uncontrolled disease, including: patients with poorly controlled blood pressure (systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg); 4.patients with myocardial ischemia or myocardial infarction of class I or higher, cardiac arrhythmia (including QT interval >= 480 ms), and cardiac insufficiency of class I; 5.active or uncontrolled severe infections; 6.hepatic disease such as decompensated liver disease, Active hepatitis B (HBV-DNA >= 104 copies/ml or 2000IU/ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method); 7.Urine routine suggesting urinary protein >= ++ and confirmed 24-hour urinary protein quantification > 1.0g; 7. Pulmonary hemorrhage with NCI CTC AE classification > grade 1 within 4 weeks prior to enrollment; 8.bleeding from other sites with NCI CTC AE classification > grade 2 within 4 weeks prior to enrollment; 9.patients with bleeding tendency (e.g., active peptic ulcer) or undergoing thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogs; 8. Those who have had an arterial/venous thrombotic event within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism; 9. patients whose imaging shows that the tumor has invaded important blood vessels or who, in the judgment of the investigator, have a high likelihood of fatal hemorrhage due to tumor invasion of important blood vessels during the follow-up study; 10. pregnant or lactating women; 11. patients with other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) 12. patients with a history of psychotropic substance abuse and unable to quit or patients with mental disorders; 13 patients who have participated in a clinical trial of another drug within four weeks; 14. patients who, in the judgment of the investigator, have a serious concomitant disease that jeopardizes patient safety or interferes with the patient's ability to complete the study 15. those who, in the judgment of the investigator, are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression free survival;Safety;Time to response;Duration Of relife;Disease control rate; | — |
Countries
China
Contacts
Public ContactQing Guo
Taizhou People's Hospital
Outcome results
None listed