Esophageal squamous cell carcinoma
Conditions
Interventions
experimental group:Carrelizumab + Paclitaxel + Nedaplatin
Sponsors
The Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Unresectable locally advanced/advanced esophageal squamous cell carcinoma diagnosed by histology (clinical stage IIIa-IVb). If patients with stage IIIa have surgical contraindications or refuse surgery, they can be treated with this program; 2. Aged 18 to 70 years, no gender limit; 3. There are measurable lesions that meet the RECIST 1.1 standard for evaluation; 4. Have not received anti-tumor treatment for esophageal cancer before surgery, including chemotherapy and local treatment; 5. ECOG PS: 0-1 points; 6. The functions of vital organs meet the following requirements: (1) The absolute count of neutrophils>=1.5x10^9/L; platelets>=100x10^9/L; hemoglobin>=9g/dL; serum albumin>=2.8g/dL; (2) Thyroid-stimulating hormone (TSH) =3 months; 8. For non-surgical sterilization or female patients of childbearing age, it is necessary to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment period; Serum or urine HCG test within 72 hours must be negative; and must be non-lactating; for men, surgical sterilization should be performed, or consent to use appropriate methods of contraception during the trial and within 3 months after the last administration of the trial drug; 9. The patient voluntarily joined the study and signed an informed consent (ICF), with good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Past or simultaneous suffering from other malignant tumors, except for fully treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 2. Active hepatitis B or C (hepatitis B: HBsAg positive and HBV-DNA>=10copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring simultaneous antiviral therapy); 3. Active pulmonary tuberculosis infection; 4. Suffer from active, known or suspected autoimmune diseases. Subjects with hypothyroidism who only need hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or hair loss) can be selected; 5. Past interstitial lung disease, or (non-infectious) pneumonia and need oral or intravenous steroid therapy; 6. Heart diseases that are not well controlled, such as: (1) New York Heart Association (NYHA) heart failure above grade 2; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Supraventricular or ventricular arrhythmias that have clinical significance and require treatment or intervention; 7. The subject is known to have been allergic to macromolecular protein preparations or any components of karylizumab; 8. Human immunodeficiency virus (HIV, HIV 1/2 antibody) positive; 9. Live vaccines have been vaccinated or will be vaccinated within 30 days before the administration of Carrelizumab; 10. Have a history of psychotropic drug abuse, alcohol or drug abuse; 11. Other factors judged by the investigator that may affect the safety of the subjects or the compliance of the trial. Such as serious diseases (including mental illness) that require combined treatment, severe laboratory abnormalities, or other family or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Progression-free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactMa Jianqun
The Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed