esophagus cancer
Conditions
Interventions
Experimental Group:Iparomlimab and Tuvonralimab Injection combined with radiotherapy
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Age: 18-75 years old, gender not limited; 3. Patients with esophageal cancer with local recurrence confirmed by histology or cytology, with or without oligometastasis;(According to the Expert Consensus on Radiotherapy for Oligometastatic Esophageal Cancer (2025 Edition), oligometastatic esophageal squamous cell carcinoma is defined as having no more than 5 metastatic lesions in 3 organs, and the number of metastatic lesions in a single organ system is no more than 3. Oligometastatic esophageal adenocarcinoma is defined as having no more than 3 metastatic lesions in a single organ or 1 lymph node station metastasis outside the region.) 4. Patients who have previously received first-line systemic treatment and progressed from local esophageal radiotherapy; 5. At least one local recurrent lesion in the esophagus is required, mainly receiving brachytherapy in the esophagus. 6. According to the RECIST 1.1 standard, there is at least one measurable target lesion; 7. ECOG score 0-1; 8. Expected survival period >=12 weeks; 9. The toxic and side effects of previous treatments (excluding hair loss, etc.) are = 1.5×10^9/L;c) Platelet count (PLT) >= 100×10^9/L; 2) Blood biochemical examination:d) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 60mL/min (Cockcroft-Gault formula);g) Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%. 11. Women of childbearing age must have a negative result of a pregnancy test (serum or urine) within 14 days before enrollment, and voluntarily adopt appropriate contraceptive methods during the observation period and within 8 weeks after the last administration of the study drug. For men, surgical sterilization should be performed or they should agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug. 12. Willing and able to accept follow-up until death or the end of the study or the termination of the study.
Exclusion criteria
Exclusion criteria: 1. The patient has uncontrollable pleural/abdominal/pericardial effusion that has received drainage within 14 days before the first administration of medication; 2. Other malignant tumors concurrent within 5 years prior to medication, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection (hormone therapy for non-metastatic prostate cancer or breast cancer is allowed); 3. Known to have central nervous system metastases and/or cancerous meningitis; 4. Patients with severe heart, lung, liver or kidney dysfunction; 5. History of immune deficiency, or other acquired or congenital immune deficiency diseases, or history of organ transplantation; 6. Systemic glucocorticoid therapy or other immunosuppressant therapy is required within 14 days before the first administration of apalolithovolrelimab;(Daily dose = 10 milligrams of prednisolone [or equivalent dose]) or other immunosuppressants treatment. Note: For patients without obvious autoimmune diseases, inhalation or local application of glucocorticoids, or adrenalin replacement therapy (daily dose >= 10 milligrams of prednisolone [or equivalent dose]) is acceptable; 7. Patients with active hepatitis B or C, or those with positive HIV antibody tests, or those with positive Treponema pallidum antibodies and positive reactivity tests; 8. Concurrent severe infection within 4 weeks before medication (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever >38.5? during screening or before the first administration; 9. Have received other anti-tumor treatments, including chemotherapy, targeted therapy, immunotherapy, Chinese patent medicines with definite anti-tumor effects, and other investigational drugs or devices, 30 days before radiotherapy or within 5 half-lives (whichever is longer); 10. Patients who are known to have hypersensitivity or allergic reactions to any component of Iparomlimab and Tuvonralimab Injection; 11. There are contraindications for brachytherapy such as possible esophageal fistula and esophageal obstruction where the donor cannot pass through at all; 12. Pregnant women or women who are breastfeedingPregnant women or women who are breastfeeding 13. Patients who are known to have abused psychotropic drugs and are unable to quit or have mental disorders; 14. The researchers identified patients who were not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiation dose exploration stage: RP2D;Extended study phase: Objective Response Rate (ORR) evaluated by the researchers; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression free survival (PFS);Disease Control Rate (DCR);During of response(DoR);Overall Survival(OS);safety;Health-related life; | — |
Countries
China
Contacts
Public ContactXiaoting Xu
The First Affiliated Hospital of Soochow University
Outcome results
None listed