Esophageal carcinoma
Conditions
Interventions
Cohort A:Camrelizumab plus cisplatin and nab-paclitaxel or paclitaxel
Cohort B:Camrelizumab plus cisplatin and nab-paclitaxel or paclitaxel
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, male or female; 2. Pathologically confirmed locally advanced resectable single-focal esophageal squamous cell carcinoma with clinical stage T2N0M0, T1b-2N M0, T3-4aNanyM0, TanyNanyM1 lymph node metastasis (confined to supraclavicular lymph nodes) [a-d]; Multifocal esophageal squamous cell carcinoma, the main lesion should be locally advanced and resectable, and the clinical stage is T2N0M0, T1b-2N M0, T3-4aNanyM0, TanyNanyM1 lymph node metastasis (confined to the supraclavicular lymph node) [a-e]; (Note: a. Clinical staging is based on AJCC 9th.) b. The clinical stage should be evaluated by ultrasound gastroscopy during the screening period, and the clinical stage should be evaluated for each lesion. c. Lymph node metastasis >= 1cm in diameter of imaging examination (CT or color ultrasound) is considered to be lymph node metastasis, and the metastasis is determined according to the SUV cut-off value of each center on PET-CT. d. Each patient should be discussed multidisciplinary by the MTD team including specialists in thoracic surgery, radiation oncology, and medical oncology. e. Count of lesions: Discontinuous lesions under ultrasound gastroscopy or PET-CT should be regarded as an independent lesion based on the comprehensive judgment of ultrasound gastroscopy, PET-CT and all available clinical evidence. ) 3. ECOG: 0~1; 4. Have not received anti-tumor therapy; 5. The function of major organs is normal, that is, the following criteria are met: (1) Routine blood examination: a. HB=90g/L; b.ANC>=1.5×10^9/L; c.PLT >=80×10^9/L; (2) Biochemical examination: a. ALB>=30g/L; b. ALT and AST =60ml/min; 6. Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >= the lower limit of normal (50%); 7. Females of childbearing potential should agree to use contraception (such as intrauterine device, contraceptive pill or condom) for the duration of the study and for 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient; Male should agree that contraception must be practiced for the duration of the study and for 6 months after the end of the study period; 8. Subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to the study drug or have metabolic disorders; 2. Patient has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; Patient has vitiligo; Asthma that has been completely resolved in childhood and does not require any intervention in adulthood may be included; Asthma in patients requiring medical intervention with bronchodilators could not be included); 3. Patients are using immunosuppressants, or systemic hormone therapy to achieve immunosuppressive purposes (dose> 10mg/day prednisone or other efficacy hormones), and continue to use them within 2 weeks before enrollment; 4. Patients with any severe/uncontrolled cardiac disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure =150mmHg or diastolic blood pressure >=100 mmHg); Heart failure with cardiac function class III-IV (NYHA classification) due to coronary heart disease, cardiomyopathy, or other causes. 5. Presence of serious other diseases: active or uncontrolled serious infection; Liver disease such as active hepatitis B (HBV-DNA> 2000IU/ml and ALT level >ULN) or hepatitis C (positive for hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method); Those whose urine routine showed a >= urine protein, and confirmed that the 24-hour urine protein quantification > 1.0g; 6. Pregnant or lactating women; 7.Patients with other malignancies within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 8. Patients with a history of psychotropic drug abuse and unable to quit or patients with mental disorders; 9. Patients who have participated in clinical trials of other drugs within four weeks; 10. According to the judgment of the investigator, patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study; 11. Those who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathologic response ,MPR;R0 resection rate;Lymph node downstaging rate;Disease-free survival,DFS;Overall survival; | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed