a study of tqb2450 in combination with intensity-modulated radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is a study to evaluate the efficacy and safety of tqb2450 injection combination with intensity-modulated radiotherapy in patients with inoperable locally recurrent nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * 1. understood and signed an informed consent form; 2. eastern cooperative oncology group (ecog) performance status of 0 to 1; life expectancy ≥ 3 months; 3. local recurrence of non-keratinizing nasopharyngeal carcinoma diagnosed by histopathology and/or cytology; clinical stage: rt2-4n0-3m0 , rii-iva phase (ajcc eighth edition); 4. the recurrence time is more than 12 months from the end of the first course of radiotherapy, without other systemic or local anti-tumor treatment; 5. at least one measurable lesion (based on recist 1.1); 6. adequate laboratory indicators; 7. no pregnant or breastfeeding women, and a negative pregnancy test. exclusion criteria: * 1. operable patients with local recurrence, including rt2 (the tumor is confined to the surface of the parapharyngeal space, and the distance from the internal carotid artery \> 0.5 cm) and rt3 (the tumor is confined to the bottom wall of the sphenoid sinus, and the distance from the internal carotid artery and cavernous sinus \> 0.5 cm) ; 2.combined diseases and medical history: 1. accompanied by nasopharyngeal necrosis, radiation brain injury, severe neck fibrosis, or other ≥grade 3 radiation complications, the investigator has assessed that the risk is extremely high and not suitable for radiotherapy; 2. has other malignant tumors within 3 years; 3. unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy; 4. has received major surgical treatment, open biopsy, or obvious traumatic injury within 28 days before the first administration; 5. long-term unhealed wounds or fractures; 6. arterial/venous thrombosis events occurred within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral; hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 7. has drug abuse history that unable to abstain from or mental disorders; 8. has any severe and/or uncontrollable disease. 3.tumor-related symptoms and treatment: 1. diagnosed local recurrence and received surgery, chemotherapy, radiotherapy or other anti-cancer therapies before first administration; 2. has received nmpa approved chinese patent medicines with anti-tumor indications; 3. has received relevant immunotherapy drugs for pd-1, pd-l1, ctla-4, etc.; 4. uncontrollable pleural effusion, pericardial effusion or ascites that still needs to be drained repeatedly (as judged by the investigator); 4.research and treatment related: 1. has vaccinated with vaccines or attenuated vaccines within 4 weeks prior to first administration; 2. have severe hypersensitivity after using monoclonal antibodies; 3. active autoimmune diseases that require systemic treatment (such as the use of disease-relieving drugs, corticosteroids, or immunosuppressive agents) occurred within 2 years before the start of the study treatment; 4. has immunodeficiency or received systemic glucocorticoid therapy or any other form of immunosuppressive therapy, and continue to use within 2 weeks of the first administration; 5.has participated in other anti-tumor drug clinical trials within 4 weeks before the study; 6.according to the judgement of the investigators, there are other factors that may lead to the termination of the study.