Advanced or metastatic urothelial carcinoma
Conditions
Interventions
trial group:Camrelizumab combined with Gemcitabine and Cisplatin
Sponsors
Affiliated Cancer Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patients volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up; 2. Patients aged 18-75 years (including boundary value); 3. Patients with advanced or metastatic urothelial cancer confirmed by histology Including bladder cancer and upper urinary tract urothelial cancer (renal pelvis cancer and ureteral cancer); 4. Patients who have not received systematic radiotherapy, chemotherapy, or immunotherapy; 5. ECoG PS: 0-1 point; 6. The functions of important organs shall meet the following requirements (not including the use of any blood components and cell growth factors during screening): (1) Neutrophil absolute count >=1.5x10^9/L; platelet >=100 x 10^9/L; hemoglobin >=9g/dl; serum albumin >=2.8g/dl; (2) TSH =3 months; 8. Female patients of non-surgical sterilization or childbearing age need to use a medically recognized contraceptive measure during the study treatment period and within 3 months after the end of the study treatment period; 72 The hCG test of serum or urine must be negative within h days, and it must be non lactation period; for men, it should be surgical sterilization, or it should be agreed to use appropriate methods of contraception during the test and within 3 months after the last administration of the test drug.
Exclusion criteria
Exclusion criteria: 1. Patients with previous or simultaneous other malignant tumors, excluding fully treated non melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma; 2. Patients who have already started radiotherapy and patients who are highly allergic to any study drugs or excipients; 3. Patients with bone marrow suppression or coagulation disorders and patients with renal impairment; 4. Patients with active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA >=10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time); 5. Patients with active tuberculosis infection within one year before the drug use should be excluded even if they have been treated; patients with active tuberculosis infection more than one year ago should be excluded unless it is proved that they have received standard anti tuberculosis treatment before; 6. Patients with active, known or suspected autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases (such as vitiligo, psoriasis or alopecia) without systemic treatment can be selected; 7. Within 6 months before entering the study, the following conditions occurred: myocardial infarction, severe/unstable angina, NYHA grade 2 or higher cardiac insufficiency, poorly controlled arrhythmia (including QTcF interval> 450 ms for males and> 470 ms for females , QTcF interval is calculated by Fridericia formula), symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism); 8. Patients receiving hematopoietic stem cell or organ transplant; 9. Patients with HIV,HIV 1/2 antibody positive; 10. Patients who have been vaccinated or will be vaccinated with live vaccine within 30 days before the administration of carrizumab; 11. Patients with a history of psychoactive substance abuse, alcoholism or drug abuse; 12. Pregnant or breastfeeding women; 13. Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases), serious laboratory abnormalities or other family or social factors that need to be treated together.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;PFS; | — |
Countries
China
Contacts
Public ContactHui Chen
Affiliated Cancer Hospital of Harbin Medical University
Outcome results
None listed