urothelial carcinoma
Conditions
Interventions
1:AK105 combinded with Anrotenib
Sponsors
The First Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, unlimited for men and women; 2. Patients with advanced urothelial carcinoma confirmed by histology or cytology; 3. Did not receive systematic treatment before; 4. ECoG 0-2 points; 5. There are measurable lesions meeting the recist1.1 standard; 6. Estimated survival time >= 3 months; 7. The function of the main organs is normal, and there is no serious abnormality of blood, heart, lung, liver and kidney no immune deficiency diseases. The laboratory inspection meets the following requirements: (1) the blood routine examination should be in accordance with (no blood transfusion within 14 days): a. HGB >= 110g/L; b. WBC >= 4.0 x 10^9/L NEUT >= 2.0 x 10^9/L; c. PLT >= 100 x 10^9/L (2) biochemical examination shall meet the following standards: bil = 50ml / min (Cockcroft Gault formula); (3) fecal occult blood (-); (4) the urine routine was normal, or the urine protein was less than (+ +), or the 24-hour urine protein was less than 1.0 g; 8. TSH is less than or equal to the upper limit of normal value (ULN); if the level of T3 and T4 is abnormal, T3 and T4 can be selected if they are normal; 9. The blood coagulation function was normal without active bleeding and thrombosis. A. international standardization ratio INR <=1.5 x ULN; B. partial thromboplastin time APTT <= 1.5 x ULN; C. prothrombin time Pt <= 1.5uln. 10. Pregnant women of childbearing age must have negative pregnancy test (serum or urine) within 14 days before entering the group, and they should voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of arotinib; for men, they should be sterilized by operation or agree to use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of arotinib; 11. The patients voluntarily joined the study and signed the informed consent form (ICF). They have good compliance and can follow up the efficacy and adverse reactions according to the scheme requirements.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously used multi-target anti vascular drugs / immunotherapy, or who have received chemotherapy within 6 months after the first application; 2. Known allergy to ak105 or enrotinib hydrochloride or any component; 3. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA >= 500 IU / ml), hepatitis C (HCV antibody positive, and HCV-RNA higher than the detection limit of the analysis method), or combined hepatitis B and hepatitis C co infection; 4. Immunosuppressive drugs have been used in the past 14 days before the first use of ak105 200mg, excluding nasal spray and inhaled corticosteroids or systemic steroids with physiological dose (i.e. no more than 10 mg / day of prednisolone or other corticosteroids with physiological dose of the same drug); or live attenuated vaccines are planned to be inoculated within 4 weeks before the first administration or during the study period; 5. Patients with hypertension who cannot be reduced to the normal range (systolic pressure 450 ms in men and 470 MS in women) and cardiac insufficiency; 7. It has many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction; 8. Urine routine indicates that urine protein is >= (+ +), or 24-hour urine protein is >= 1.0g; 9. Hemoptysis within 3 months before the study; 10. Thrombotic diseases exist, requiring long-term anticoagulation with warfarin or heparin, or long-term antiplatelet therapy (aspirin >= 300 mg / day or clopidogrel >= 75 mg / day); 11. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever of unknown cause occurred during screening / before the first administration > 38.5 degree C; 12. Excessive operation, open biopsy or significant trauma within 28 days before admission; 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures; 15. Other situations that the researchers think are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;DCR;Safety;Quality of life; | — |
Countries
China
Contacts
Public ContactYang Bo
The First Medical Center of PLA General Hospita
Outcome results
None listed