esophageal squamous cell carcinoma
Conditions
Interventions
Envafolimab group:Envafolimab in combination with endostar and concurrent chemoradiotherapy
Sponsors
First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects are willing to join this study, can complete the signing of informed consent, and have good compliance; 2. Aged 18-75 (when signing the informed consent form); 3.ECOG score 0-1; 4. Predicted survival >=12 weeks; 5. Pathological specimens can be provided for biomarker detection; 6. The diagnosis was confirmed by histological examination and/or cytology, and was locally advanced and unresectable by imaging evaluation Esophageal carcinoma T3-4N0M0, TXN1-2M0,TxNxM1a(cervical lymph node metastasis only); And judged by the doctor,Patients with locally advanced, unresectable esophageal cancer who were eligible for the treatment regimen included in this study; 7. Never received radiotherapy or anti-angiogenic drugs before; Has not received immune checkpoint drug therapy for PD-1, PD-L1 or other related immune checkpoint drugs; 8. According to the response evaluation criteria RECIST 1.1 for solid tumors, the patient had at least one measurable lesion, that is, the longest diameter of a single lesion was >=10mm in CT or MRI examination, or the lymph node was pathologically enlarged, and the short diameter of a single lymph node was >=15mm in CT scan; 9. The major organs are functioning well and meet the following criteria: 1) Routine blood test (without blood transfusion or hematopoietic stimulator drugs within 14 days) : hemoglobin (Hb) >=90g/L; Absolute neutrophil count (ANC) >=1.5*10^9/L; Platelet (PLT) >=100*10^9/L; 2) Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =60mL/min; 3) Coagulation function: activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) =50%; 5) Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH was beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range could also be enrolled; 6) The doctor's clinical judgment has sufficient organ function. 10.Fertile subjects must have used an appropriate method of contraception during and 120 days after the study, had a negative serum pregnancy test within 7 days prior to study enrollment, and had to be non-lactating subjects.
Exclusion criteria
Exclusion criteria: 1.The patient had or currently has other malignant tumors within 5 years before the start of the study; 2. Unrelieved toxic effects of grade 1 or greater due to any prior treatment (according to the latest version of the National Cancer Institute [NCI] Common Terminology Standard for Adverse Events [CTCAE]), excluding hair loss and fatigue; Neurotoxicity was required to recover to =150mmHg or diastolic blood pressure >=100mmHg); 2) Patients with >= grade 2 myocardial ischemia or infarction, arrhythmias (QTc>=470ms), and >= grade 2 congestive heart failure (NYHA classification); 3) Active or uncontrolled severe infection (>=CTCAE grade 2 infection); 4) Liver cirrhosis, active hepatitis *; * Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA test above the upper limit of normal; HCV reference: HCV antibody positive, and HCV virus titer test value exceeds the upper limit of normal value); Note: Subjects who are eligible for inclusion, hepatitis B surface antigen positive or core antibody positive, and hepatitis C patients need continuous antiviral therapy to prevent virus activation. 5) Patients with active syphilis; 6) Patients with renal failure requiring hemodialysis or peritoneal dialysis; 7) Have a history of immunodeficiency, including being HIV positive or suffering from other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 4. Poor diabetes control (fasting blood glucose [FBG] > 10mmol/L); 5. Patients who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of study treatment; Or a wound or fracture that hasn't healed for a long time 6. Serious arteriovenous thrombotic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the start of study treatment; 7. Those who have a history of psychotropic drug abuse and are unable to quit or have mental disorders; 8. Tumor-related symptoms and treatment: 1) had received surgery, chemotherapy, small molecule targeted therapy, radiotherapy, or other antitumor therapy within 4 weeks before the start of study therapy (the washout period was calculated from the end of the last treatment); He had received previous radiation therapy to the chest. 2) Those who had received Chinese proprietary drugs (including compound Cantharidus capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, and cinobufin capsule) with anti-tumor indications in the NMPA approved drug label within 2 weeks before the start of the study treatment; 3) Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites (as determined by the investigator) that still require repeated drainage; 4) Subjects with known CNS metastases and/or carcinomatous meningitis; 9. Study treatment related: 1) History of live attenuated vaccine inoculation within 14 days before the start of study therapy or planned live attenuated vaccine inoculation during the study; 2) Severe hypersensitivity after using monoclonal antibody; 3) An active autoimmune disease requiring systemic treatmen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free survival (PFS);Disease control rates (DCR);Duration of relief (DOR);Overall Survival (OS);Adverse Event Rate;Serious Adverse Events;Tumor Mutation Burden;Microsatellite Instability; | — |
Countries
China
Contacts
Public ContactFan Ruitai
Outcome results
None listed