Urothelial cancer
Conditions
Interventions
Positive:Combination of penpulimab and Anlotinib
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old, gender not limited; 2. Histologically or cytologically confirmed diagnosis of advanced/unresectable (inoperable) or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies); 3. No prior systemic chemotherapy for metastatic disease (adjuvant or neoadjuvant platinum-based chemotherapy with recurrence >12 months since completion of therapy is allowed); 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 5. Measurable disease by RECIST v1.1; 6. Expected survival >= 3 months; 7. Adequate organ function; 8. Female participants must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use appropriate methods of contraception during observation and 8 days after administration of Anlotinib Tablets; 9. Male participants should be surgically sterile or agree to use appropriate methods of contraception during the observation period and after 8 days of administration of anlotinib.
Exclusion criteria
Exclusion criteria: 1. Patients previously treated with multi-target anti-vascular drugs/immunotherapy, or patients treated with chemotherapy within 6 months of the first dose; 2. Patients with known hypersensitivity to penpulimab or anlotinib hydrochloride or any component; 3. Known human immunodeficiency virus (HIV) or known active Hepatitis B or C; 4. Previous use of immunosuppressive drugs within 14 days before the first use of pianplerumumab, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids or 4 times before the first dose or planned vaccination with live attenuated vaccines during the study; 5. Patients with hypertension, which cannot be reduced to the normal range by antihypertensive drug treatment (systolic blood pressure = grade 2 coronary heart disease, arrhythmia, and cardiac insufficiency; 7. There are a variety of factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction; 8. Urinalysis suggests urine protein >= (++), or 24-hour urine protein >= 1.0g; 9. hemoptysis within 3 months before entering the study; 10. Presence of thrombotic disease requiring long-term anticoagulant therapy with warfarin or heparin, or requiring long-term antiplatelet therapy; 11. Complicated with severe infection (such as: requiring intravenous drip of antibiotics, antifungal or antiviral drugs) before the first dose or unexplained fever > 38.5 during screening/before the first dose; 12. Excessive surgery, open biopsy, or significant trauma within 28 days before enrollment; 13. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 14. Pregnant or lactating women; 15. other conditions that the investigator considers inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Quality of life improvement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS);Overall survival (OS);DCR; | — |
Countries
China
Contacts
Public ContactYang Bo
Chinese PLA General Hospital
Outcome results
None listed