Locally advanced esophageal squamous cell carcinoma
Conditions
Interventions
Case series:Camrelizumab combined with paclitaxel and nedaplatin
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with resectable locally advanced esophageal squamous cell carcinoma (clinical stage iia-iiib) confirmed by histology; 2. male and female patients aged 18-70 years old; 3. There are measurable patients and evaluable lesions that meet the criteria of RECIST 1.1; 4. Patients who have not received anti-tumor treatment for esophageal cancer before operation, including chemotherapy and local treatment; 5. ECoG PS: 0-1 point; 6. The functions of important organs shall meet the following requirements: (1) Neutrophil absolute count >=1.5x10^9/L; platelet >=100x10^9/L; hemoglobin >=9g/dl; serum albumin >=2.8g/dl; (2) TSH =3 months; 8. Female patients of non-surgical sterilization or childbearing age need to use a medically recognized contraceptive measure during the study treatment period and within 3 months after the end of the study treatment period; 72 The hCG test of serum or urine must be negative within h days, and it must be non lactation period; for men, it should be surgical sterilization, or it should be agreed to use appropriate methods of contraception during the test and within 3 months after the last administration of the test drug; 9. The patient volunteered to join the study and signed the informed consent form (ICF), with good compliance and follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients with previous or simultaneous other malignant tumors, excluding fully treated non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 2. Patients with active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA >=10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time); 3. Patients with active tuberculosis infection within one year before the drug use should be excluded even if they have been treated; patients with active tuberculosis infection more than one year ago should be excluded unless it is proved that they have received standard anti tuberculosis treatment before; 4. Patients with active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment can be selected; 5. Patients with interstitial lung disease or (non infectious) pneumonia who need oral or intravenous steroid therapy; 6. patients with uncontrolled heart disease, such as: (1) NYHA grade 2 heart failure; (2) Unstable angina; (3) Myocardial infarction occurred within one year; (4) Supraventricular or ventricular arrhythmias that have clinical significance and need treatment or intervention; 7. It is known that the subjects were previously allergic to the macromolecular protein preparation or any component of carrizumab; 8. Patients with HIV positive; 9. Patients who have been vaccinated or will be vaccinated with live vaccine within 30 days before the administration of carrizumab; 10. Patients with a history of psychoactive substance abuse, alcoholism or drug abuse; 11. Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases), serious laboratory abnormalities or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DFS; | — |
Countries
China
Contacts
Public ContactJianqun Ma
Affiliated Tumor Hospital of Harbin Medical University
Outcome results
None listed