Postoperative T2~4N1~2M0 stage esophageal cancer
Conditions
Interventions
test group:Paclitaxel (135-175 mg/m2) + nedaplatin (80 mg/m2)/cisplatin (75~100mg/m2) or carboplatin (AUC=5~7) + carrelizumab (200 mg) , Simultaneous or sequential radiotherap
Control group:Paclitaxel (135-175 mg/m2) + nedaplatin (80 mg/m2)/cisplatin (75~100mg/m2) or carboplatin (AUC=5~7) +placebo, simultaneous or sequential radiotherap.
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria of esophageal cancer (1) Locally advanced esophageal cancer (T2 ~ 4n1 ~ 2m0) which was confirmed by histology or cytology and could not be treated radically; (2) If there is no risk of massive hemorrhage or esophageal fistula, for example, if the lesion has a large ulcer, it is considered that there is a risk of massive hemorrhage and esophageal fistula, it is not suitable for inclusion. Subjects with direct invasion of adjacent organs such as aorta or trachea (T4b disease) should closely assess the risk of bleeding before enrollment, and need to consult the sponsor before enrollment. 2. General selection requirements: (1) Sign informed consent; (2) Male or female aged 18 years or above and = 75 years; (3) ECoG score was 0 or 1; (4) The expected survival was more than 3 months; (5) We agreed to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissues for biomarker analysis. 3. Good organ function includes Hematology: leukocyte = 4 × 10 ^ 9 / L, neutrophil = 2 × 10 ^ 9 / L, hemoglobin = 9 g / dl, platelet = 100 × 10 ^ 9 / L. Liver function: bilirubin = 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level = 3 times ULN can be enrolled), AST and alt = 2.5 times ULN (AST / ALT = 5 times ULN in case of liver metastasis), and alkaline phosphatase = 3 times ULN (ALP = 5 times ULN in case of liver or bone metastasis); albumin = 3G/ DL; international normalized ratio (INR), prothrombin time (PT) or activated partial thromboplastin time (APTT) = 1.5 fold ULN. Renal function: serum creatinine = 1.5 fold ULN and estimated by Cockcroft Gault glomerular filtration rate: creatinine clearance rate = 60 ml / min (140 age) (body weight, kg) (0.85, if female) 72 (serum creatinine, mg / dl) or: (140 age) (body weight, kg) (0.85, if female) 0.818 (serum creatinine, µ mol / L) 4. Female patients who met the following criteria were eligible to participate in the study: Women who are infertile (such as physiologically unable to conceive) and meet any of the following conditions: hysterectomy; bilateral oophorectomy (oophorectomy); bilateral tubal ligation; or postmenopausal (total time of menopause = 1 year). Fertility, negative serum pregnancy test at screening (within 7 days before the first administration of the study drug), and From before entering the study and during the whole study period until 60 days after the last use of the study drug, adequate contraceptive measures were taken. According to the instructions of contraceptive products and the instructions of doctors, continuous and adequate contraceptive measures are defined as follows: intrauterine devices with proven contraceptive failure rate less than 1% per year. Double barrier contraception is a condom with sperm killing jelly, foam, suppository or film, or a contraceptive film with sperm killing agent, or a male condom and contraceptive membrane. 5. The subjects voluntarily joined the study with good compliance and follow-up; 6. Patients who the researchers believe can benefit.
Exclusion criteria
Exclusion criteria: 1. Patients with other malignant tumors in the past or at the same time; 2. Pregnant or lactating women; 3. Patients with grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including QTc interval >= 450 ms) and grade III-IV cardiac insufficiency according to NYHA standard; cardiac color Doppler ultrasound examination: LVEF (left ventricular ejection fraction) 10mg / day prednisone or other therapeutic hormones) and continues to use it within 2 weeks before signing the informed consent; 7. Subjects with known history of severe allergy to any monoclonal antibody or antiangiogenesis targeting drug; 8. Subjects with severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications; oral or intravenous administration of therapeutic antibiotics within 2 weeks prior to the start of study treatment (patients receiving prophylactic antibiotics (for example, those who prevent urinary tract infection or exacerbation of chronic obstructive pulmonary disease are eligible to participate in the study); and; 9. Patients with congenital or acquired immune deficiency (such as HIV infected patients); 10. Patients with mental illness or history of psychotropic drug abuse; 11. Patients who participated in clinical trials of other drugs within 4 weeks; 12. According to the judgment of the researcher, there are patients with accompanying diseases that seriously endanger the safety of patients or affect the completion of the study; 13. Subjects considered unsuitable by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;QoL; | — |
Countries
China
Contacts
Public ContactMa Jie
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed