esophageal cancer
Conditions
Interventions
Group A:2 cycles Camrelizumab in combination with chemotherapy
Group B:3 cycles Camrelizumab in combination with chemotherapy
Sponsors
The First Affiliated Hospital, College of Medicine, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old, male or female; 2. Participants signed a written informed consent; 3. Patients with locally advanced thoracic esophageal squamous cell carcinoma diagnosed by histopathology or cytology; 4. Patients with esophageal squamous cell carcinoma whose clinical stage is IIB-IVA stage determined by but not limited to imaging examination and multidisciplinary discussion (MDT), and who can undergo routine radical esophagectomy under the doctor's advice; 5. Physical condition ECOG PS score: 0-1 points; 6. Expected survival period >= 6 months; 7. There are no surgical contraindications for preoperative organ function examination; 8. Laboratory inspection indicators meet the following requirements: (1) Bone marrow function: hemoglobin (Hb)>= 90 g/L; white blood cell count (WBC)>= lower limit of normal; absolute neutrophil (ANC)>= 1.5×10^9/L; platelet count>= 100×10^9/L; (2) Renal function: Cr = 55 ml/min; (3) Liver function: total bilirubin <= ULN×1.5; ALT and AST <= ULN×2.5; (4) Coagulation function: the international normalized ratio of prothrombin time is less than or equal to ULN×1.5, and the partial thromboplastin time is within the normal range; 9. Have not received any treatment for esophageal cancer in the past, including surgery, chemotherapy, radiotherapy, targeted, hormone or immunotherapy; 10. Females of childbearing age agree to contraception during the study period and within 6 months after the end of the study; serum or urine pregnancy test is negative within seven days before the study is enrolled, and non-lactating patients; males agree to be in the study period and within 6 months after the end of the study contraceptive patients; 11. Those who have not participated in clinical trials of other drugs within 4 weeks before enrollment; 12. Patients with good compliance are expected to be able to follow up the efficacy and adverse reactions according to the requirements of the program; 13. The patients under observation have signed the informed consent to participate in the experimental treatment; 14. Informed consent form of the observed patient agreeing to participate in this observational study.
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors have been diagnosed in the past 5 years; 2. There is metastasis to distant organs; 3. Unable to quit drinking successfully or with withdrawal syndrome; 4. Patients with any active autoimmune disease or autoimmune disease (including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vascular inflammation, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Type 1 diabetes mellitus receiving stable doses of insulin, hypothyroidism receiving only hormone replacement therapy, no systemic therapy required, and no acute exacerbation of skin disease (eg, eczema, vitiligo, or psoriasis) within 1 year prior to the screening period.); 5. Suffering from uncontrolled clinical symptoms or diseases of the heart; 6. Active infection or fever (except for definite tumor fever); 7. Patients with immunodeficiency and active hepatitis; 8. Those who have received PD-1 or PD-L1 antibody therapy in the past; 9. Those who are allergic to any drugs in this program; 10. Live vaccines within 4 weeks before the study medication or possibly during the study period; 11. Those who used immunosuppressive drugs or corticosteroids > 10 mg/day of prednisone within 14 days before enrollment; 12. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 resection rate;Three-year disease-free survival rate;Major pathological response rate;Three-year overall survival rate;Surgical complications and safety; | — |
Countries
China
Contacts
Public ContactPeng Ye
Outcome results
None listed