esophageal cancer
Conditions
Interventions
Experimental group:1. Camrelizumab: 200mg, IV, D1, Q3W
2. Chemotherapy regimen: paclitaxel injection+carboplatin
3. Radiotherapy plan: radiotherapy for primary esophageal lesions can be selected, using 2Gy/1f, DT=50Gy
and (or) For = 1 metastatic lesion, the specific dosage of SBRT is determined by the attending physician.
control group:1. Camrelizumab: 200mg, IV, D1, Q3W
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
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. Age: = 18 years old and = 75 years old, regardless of gender; 3. Newly diagnosed patients with stage IV esophageal cancer confirmed by histopathological and imaging examinations, with oligometastatic lesions of = 5/3 organs; 4. Have not received any systematic anti-tumor treatment for advanced/metastatic diseases in the past. For patients who have previously received adjuvant/neoadjuvant chemotherapy, or who have received curative radiotherapy and chemotherapy for advanced diseases, if the interval between disease progression or recurrence and the end of last drug treatment is at least 6 months, they are allowed to be included in this study; 5. Patients with brain metastases who are asymptomatic or have stable symptoms after local treatment are allowed to be included, and they must meet the following conditions: 1) Measurable lesions outside the central nervous system 2) No central nervous system symptoms or no worsening of symptoms for at least 2 months 3) No need for glucocorticoid treatment or discontinuation of glucocorticoid treatment within 3 days before the first study drug administration. 6. ECOG score 0-1 points; 7. Expected survival time>3 months; 8. The main organ function is good, and the relevant examination indicators within one week before enrollment meet the following requirements: blood routine examination: a Hemoglobin content (HB) = 90g/L (no blood transfusion within 28 days); b. Absolute neutrophil count (ANC) = 1.5 × 10 ^ 9/L; c. Platelet count (PLT) = 100 × 10 ^ 9/L; Biochemical examination: a Total serum bilirubin (TBIL) = 1.5 times the upper limit of normal value (ULN); b. Blood alanine aminotransferase (ALT) and blood aspartate aminotransferase (AST) = 2 × ULN; c. Plasma Cr = 1.5 × ULN; 9. For female participants of childbearing age, they should undergo a urine or serum pregnancy test with a negative result within 3 days prior to receiving the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non reproductive age women are defined as those who have experienced at least one year after menopause, or have undergone surgical sterilization or hysterectomy; 10. If there is a risk of conception, all subjects (whether male or female) are required to use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration). 11. Previously did not undergo anti-tumor treatment, including surgery, chemotherapy, radiotherapy, and targeted therapy; 12. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Patients who meet the following criteria are not eligible for admission to this study: 1. Unable to tolerate digestive endoscopy biopsy; 2. Have clear concerns about gastrointestinal bleeding (such as local active ulcer lesions and positive fecal occult blood); Have a history of gastrointestinal bleeding within 6 months; 3. Have had other active malignant tumors within the 5 years prior to entering the study. Except for skin basal cell or squamous cell carcinoma, superficial bladder cancer carcinoma, cervical carcinoma in situ, breast intraductal carcinoma in situ and thyroid papillary carcinoma that can be treated locally and have been cured; 4. Prior to the first study treatment, the following treatments or medications were received: a. Major surgery was performed within 28 days prior to the first study drug treatment (tissue biopsy required for diagnosis is allowed); b. Within 28 days before the first study drug treatment or within 60 days after the end of the study drug treatment, the attenuated live vaccine is planned to be administered during the study period; c. Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days prior to the first study of drug therapy; 5. Existence of any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controlled only by hormone replacement therapy may be included] ; Subjects with skin diseases that do not need systemic treatment, such as vitiligo, psoriasis, alopecia, type I diabetes, or asthma in childhood has been completely alleviated, and adults do not need any intervention can be included; Asthma patients who require medical intervention with bronchodilators cannot be included; 6. Pregnant or lactating women; 7.Within the 6 months prior to entering the study, patients with myocardial infarction, severe/unstable angina, NYHA grade 2 or above cardiac dysfunction, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 8. Systemic use of antibiotics for = 7 days within 4 weeks prior to the first administration, or unexplained fever>38.5 ° C occurring during screening/before the first administration (according to the researcher's judgment, fever caused by tumor can be included in the study); 9. Central nervous system metastasis has occurred; 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), Untreated active hepatitis (hepatitis B, defined as positive detection result of hepatitis B B virus surface antigen [HBsAg], HBV-DNA = 500 IU/ml and abnormal liver function; hepatitis C, defined as positive detection of hepatitis C antibody [HCV Ab], HCV-RNA higher than the detection limit of the analytical method and abnormal liver function) or co infection of hepatitis B and hepatitis C; 12. Have participated in any other clinical studies of drugs within 4 weeks prior to the first administration; 13. Have a clear history of neurological or psychiatric disorders, including epilepsy and dementia; Known history of abuse of psychotropic substances, alcoholism, or drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Disease control rate (DCR);Objective response rate (ORR);PFS rates at 6 and 12 months;OS rates at 12 and 24 months;Treatment related AEs (CTCAE5.0 standard); | — |
Countries
china
Contacts
Public ContactWei Huang
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed