a study of tqb2450 injection combined with anlotinib hydrochloride capsule in subjects with advanced endometrial cancer

Conditions: Advanced Endometrial Cancer

Summary: this is a study to evaluate the efficacy and safety of tqb2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer.


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. histopathologically confirmed recurrent or metastatic advanced endometrial cancer. 4. has at least one measurable lesion. 5. agree to provide tumor tissue samples for msi/mmr status detection. 6. adequate laboratory indicators. 7. serum or urine pregnancy tests are negative within 7 days before randomization; men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months. exclusion criteria: * 1.concomitant disease and medical history: 1. has diagnosed and/or treated additional malignancy within 3 years prior to randomization; 2. pathological diagnosed as uterine sarcoma; 3. has multiple factors affecting oral medication; 4. unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy. 5. has received major surgical treatment, open biopsy and so on within 28 days before the start of the study. 6. has a unhealed wound or fracture for a long time; 7. has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study; 8. has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; 9. has a history of psychotropic substance abuse and unable to quit or mental disorders; 10. has any serious and / or uncontrolled disease; 2. tumor-related symptoms and treatment: 1. has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study; 2. has received proprietary chinese medicine with anti-tumor indications in the nmpa approved drug instructions within 2 weeks before the start of the study; 3. has received immunotherapeutic drugs against pd-1, pd-l1, ctla-4 and other related drugs; 4. has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib, etc; 5. has received hormone therapy for endometrial cancer within a week before the first dose ; 6. ct or mri showed that the tumor had invaded the important blood vessels; 7. has symptomatic central nervous system (cns) disease and/or cancerous meningitis, pia mater disease; 3. related to research and treatment: 1. has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period. 2. has a history of severe allergic diseases. 3. has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study. 4. has participated in other clinical trials within 4 weeks before first dose. 5. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.