esophagus cancer
Conditions
Interventions
Single arm group:No
Sponsors
Affiliated Cancer Hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18 to 75 years, gender is not limited; 3. Newly diagnosed patients, stage IV esophageal cancer diagnosed by histopathology and imaging examination, with measurable oligometastases 3 months; 7. The main organ function is good, that is, the relevant inspection indicators meet the following requirements within 1 week before enrollment: blood routine examination: hemoglobin content (HB) >= 90g/L (no blood transfusion within 28 days); absolute neutrophil count (ANC)>=1.5x10^9/L; platelet count (PLT) >=100x10^9/L; biochemical tests: serum total bilirubin (TBIL) <=1.5 times the upper limit of normal (ULN); blood alanine aminotransferase (ALT) ) and blood aspartate aminotransferase (AST)<=2xULN; plasma Cr<=1.5xULN; 8. For female subjects of childbearing age, a urine or serum pregnancy test should be taken within 3 days prior to receiving the first dose of study drug (Day 1 of Cycle 1) with a negative result. If a urine pregnancy test result cannot be confirmed negative, a blood pregnancy test is required. Women of non-reproductive age are defined as having been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; 9. If there is a risk of conception, all subjects (regardless of male or female) are required to use the drug throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy drug) Low annual failure rate less than 1% of contraceptives; 10. No prior anti-tumor treatment, including surgery, chemotherapy, radiotherapy and targeted therapy;The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Have clear concerns about gastrointestinal bleeding (such as local active ulcer lesions, positive fecal occult blood); have a history of gastrointestinal bleeding within 6 months; 2. Suffering from other active malignant tumors within 5 years before entering the study. Except for locally treatable and cured basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary thyroid carcinoma; 3. Received the following treatments or drugs before the first study treatment: Major surgery within 28 days before the first study drug treatment (tissue biopsy due to diagnosis is allowed); 28 days before the first study drug treatment or planned within 28 days Vaccination with live attenuated vaccine during the study period and within 60 days after the end of study drug treatment; 4. There is any active autoimmune disease or history of autoimmune disease and expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis , hyperthyroidism, hypothyroidism [subjects that can only be controlled by hormone replacement therapy can be included]; subjects with skin conditions that do not require systemic treatment such as vitiligo, psoriasis, alopecia, type 1 diabetes or Patients whose asthma has been completely resolved in adulthood without any intervention can be included; 5. Pregnant or lactating women; 6. Systemic use of antibiotics for >= 7 days within 4 weeks before the first administration, or unexplained fever >38.5°C during the screening period/before the first administration (as judged by the investigator, fever due to tumor can be included in the group) ; 7. Central nervous system transfer has occurred; 8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); 10. Participated in any other drug clinical research within 4 weeks before the first administration; 11. There is a clear history of neurological or psychiatric disorders, including epilepsy and dementia; known history of psychotropic substance abuse, alcoholism or drug use; 12. Known allergy to the study drug or any of its excipients; or have had severe allergic reactions to other monoclonal antibodies; medical history or disease evidence, treatment or laboratory test values ??that may interfere with the test results and prevent subjects from participating in the study throughout the study Abnormal, or other circumstances that the investigator considers unsuitable for enrollment, the investigator considers that there are other potential risks and are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;toxic reaction; | — |
Secondary
| Measure | Time frame |
|---|---|
| short-term effects; | — |
Countries
China
Contacts
Public ContactHuang Wei
Affiliated Cancer Hospital of Shandong First Medical University
Outcome results
None listed