Advanced esophageal squamous cell carcinoma
Conditions
Interventions
FP group:Fluorouracil plus platinum plus camrelizumab
TP group:Taxanes plus platinum plus camrelizumab
Sponsors
Changzhi People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with esophageal squamous cell carcinoma confirmed by histology or cytology, and locally advanced unresectable or with distant metastasis; tissue samples should be accessible for detection of PD-L1; 2. male and female patients aged >=18 years old; 3. Patients who have not received systematic anti-tumor therapy before. For patients who have received neoadjuvant / adjuvant and radical concurrent chemoradiotherapy, the time from the last chemotherapy to relapse or progression is more than 6 months, and for patients with radiotherapy alone, screening can be performed after disease progression; 4. According to RECIST 1.1, patients with at least one measurable lesion should not have received local treatment such as radiotherapy (target lesions located in the previous radiotherapy area can also be selected as target lesions if it is confirmed that they have progressed and meet recist1.1 criteria.); 5. ECoG: 0-1 patients; 6. Patients with expected survival time >=12 weeks; 7. Patients whose functions of important organs meet the following requirements (no blood components and cell growth factors are recommended 2 weeks before the start of the study and treatment) (1) Absolute neutrophil count (ANC) >=1.5 x 10^9/L; (2) Platelet >=100 x 10^9/L; (3) Hemoglobin >= 9g/dl; (4) Serum albumin >= /dl; (5) Bilirubin = 50ml/ min; (7) Activated partial thromboplastin time (APTT) and international normalized ratio (INR) were less than 1.5 ULN (for anticoagulant therapy with stable dose such as low molecular weight heparin or warfarin, and INR can be screened within the expected treatment range of anticoagulants); 8. Fertile female subjects should have a urine or serum pregnancy test within 72 hours prior to administration of the first study drug and have been shown to be negative, and willing to use effective contraceptive methods from the trial period to 3 months after the last administration of carrizumab (control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective contraceptive methods should be used during the trial period and within 3 months after the last administration of carrizumab (from the control group to 180 days after the last administration); 9. The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up; 10. The researchers determined that the patients could receive the combination therapy of carrizumab.
Exclusion criteria
Exclusion criteria: 1. Patients who have been diagnosed with other malignant tumors within 5 years before the first use of the study drug, except for skin basal cell carcinoma, skin squamous cell carcinoma and / or cervical cancer in situ and / or breast cancer after effective treatment; 2. Patients with history of gastrointestinal perforation and / or fistula within 6 months before the first medication; 3. Patients with high risk of bleeding or fistula due to tumor invasion into adjacent organs (artery or trachea) of esophageal lesions; 4. Patients with uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 5. Patients with any active autoimmune disease or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (hormone replacement therapy can be included after normal hormone replacement therapy)); patients with vitiligo or asthma in childhood have been completely relieved, and do not need any intervention in adulthood Asthma patients who need bronchodilators for medical intervention can not be included; 6. Suffering from uncontrolled clinical symptoms or diseases of the heart, for example: (1) NYHA grade II or above heart failure; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias need clinical intervention; 7. Patients with severe infection (CTC AE > 2) within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. in need of hospitalization; baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection 2 weeks before the first use of the study drug, or need oral or intravenous use of anti-inflammatory drugs The use of antibiotics was excluded; 8. History or evidence of interstitial lung disease or active non infectious pneumonia is known; 9. Patients with congenital or acquired immune deficiency (e.g. HIV infection), active hepatitis B (hbv-dna2000 IU / ml or >=104 copies / ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method); 10. Patients who have previously received other PD-1 antibody therapy or other immunotherapy for PD-1 / PD-L1; 11. Patients who are known to be allergic to macromolecular protein preparations, or to any components of carrizumab, or have allergies, hypersensitivity or contraindications to fluorouracils, platinum or any component used in their preparations; 12. Subjects requiring systematic treatment with corticosteroids (> 10 mg / day of equivalent prednisone dose) or other immunosuppressants within 14 days before the first use of the study drug; 13. Patients whose toxicity of previous anti-tumor therapy did not recover to < CTC AE grade 1 (except alopecia) or the level specified in the inclusion / exclusion criteria; 14. Pregnant or lactating women; 15. According to the researcher's judgment, the subject has other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases (including mental illness), requiring combined treatment, serious abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of test data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;Safety; | — |
Countries
China
Contacts
Public ContactXiaoling Zhang
Changzhi People's Hospital
Outcome results
None listed