esophageal cancer
Conditions
Interventions
1:Toripalimab after concurrent chemoradiotherapy
Sponsors
Jinhua Municipal Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) All participants are required to sign an informed consent form before starting the research related procedures; 2) All patients aged = 18 years and = 70 years; 3) Esophageal cancer confirmed by histology or cytology (squamous cell carcinoma); 4) The clinical stage is II-IVa, it is deemed inoperable by the surgeon or the patient refuses surgery; 5) AJCC Eighth Edition Phase II-IVa; 6) The subject confirmed to have at least one measurable lesion according to the RECIST 1.1 standard; 7) The subjects have not received any anti-tumor treatment such as radiotherapy, chemotherapy, immunotherapy, or biological therapy for esophageal cancer in the past; 8) ECOG PS 0-1 points; 9) Expected survival time = 12 weeks; 10) No blood transfusion or blood products were received within 14 days before the first administration, and G-CSF and other hematopoietic stimulating factors were not used for correction; 11) The first administration is within 30 days after the completion of radiotherapy; 12) Before the first dose of the study drug, the laboratory test values meet the following conditions: (1) Blood routine: WBC = 3.0 × 109/L; ANC = 1.5 × 109/L; PLT = 70 × 109/L; HGB = 9.0g/dL; ; (2) Liver function: AST = 2.5 × ULNin subjects without liver metastasis ; ALT = 2.5 × ULN, Liver Metastasis Subject's ALT and AST1.5 × ULN without clinical or imaging confirmation,Pancreatitis can be included in the group; Amylase = 1.5 × ULN, if Amylase>1.5 × ULN can be included if there is no clinical or imaging confirmed pancreatitis; ALP = 2.5 × ULN, bone metastasis subject, ALP = 5 × ULN.
Exclusion criteria
Exclusion criteria: 1) Previous or concurrent incurable malignant tumors, excluding cured skin Basal-cell carcinoma, cervical Carcinoma in situ and superficial bladder cancer; 2) Pathological findings were Small-cell carcinoma, adenocarcinoma or mixed carcinoma of the esophagus; 3) The primary focus of esophagus is closely related to tracheobronchial and Great vessels, and the researchers assess that there is a high risk of perforation and massive hemorrhage; 4) Previously received any T cell co stimulation or immune checkpoint therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other drugs targeting T cells; 5) Prior to this radical radiotherapy, those who have received other chest radiation treatments in the past; 6) Previously received anti VEGF or VEGFR treatment; 7) Use Corticosteroid hormone (>10mg/day prednisone or Equivalent dose) or other Immunosuppressive drug = 14 days before the first dose of study drug; 8) Use aspirin (>325 mg/day) or other Nonsteroidal anti-inflammatory drug known to inhibit platelet function within 10 days before receiving the first dose of study drug; 9) Have experienced autoimmune diseases within the two years prior to the first study of the drug, or have patients with immune deficiency diseases; 10) Interstitial lung disease, or severe pulmonary dysfunction; 11) Subjects who have received or plan to receive live vaccines within = 4 weeks prior to the first study drug; 12) Subjects who experienced side effects of anti-tumor therapy before the first dose of study, CTCAE4.03 = level 2, but were unable to recover to level 1; 13) Known to be allergic to drugs or excipients, and known to have severe allergic reactions to any type of monoclonal antibody; 14) Significant physical or psychological damage cannot guarantee the complete progress of radiotherapy and immune consolidation therapy; 15) According to the judgment of the researchers, the subjects may have other factors that may cause the study to be terminated midway, such as inability to follow up regularly, non-compliance with the protocol, other serious illnesses (including mental illness) requiring concurrent treatment, serious laboratory test abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples; 16) Patients with radiation pneumonia of grade II or above after radiotherapy and chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Serious adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactShubo Ding
Jinhua Municipal Central Hospital
Outcome results
None listed