Urothelial squamous cell carcinoma, urothelial adenocarcinoma
Conditions
Interventions
Experimental group:Vidicitumab + Camrelizumab
Sponsors
The Third Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before implementing any trial-related procedures; 2. Aged 18-85 years; 3. ECOG score 0-1 points; 4. The subject has received platinum-based chemotherapy combined with paclitaxel or gemcitabine, and the disease has progressed; or platinum is intolerant, and the disease has progressed after chemotherapy with paclitaxel or gemcitabine; 5. Urothelial squamous cell carcinoma and urothelial adenocarcinoma with histopathological diagnosis (including origin from renal pelvis, ureter, and urethra are allowed to contain other histological variation components); 6. The tumor is diagnosed with locally advanced or metastatic disease that cannot be surgically removed or recurs after surgical treatment, and has received at least conventional chemotherapy before treatment failure. The conventional chemotherapy regimen contains gemcitabine, platinum and taxane. Disease progression or relapse within 6 months after the end of neoadjuvant/adjuvant chemotherapy, such as neoadjuvant/adjuvant chemotherapy and subsequent treatment including the above three chemotherapy drugs, can meet this requirement. HER2 expression confirmed by central laboratory: IHC 2+; subject can provide primary or metastatic tumor specimens for HER2 detection; 7. There is at least one measurable lesion specified by RECIST1.1 (the measurable lesion has not received radiotherapy); the tumor lesion at the site of previous radiotherapy is considered measurable if it proves that there is progress at the time of study enrollment; 8. Expected survival period >= 3 months; 9. The main organ functions are normal (14 days before enrollment), that is, adequate heart, bone marrow, liver, and kidney functions; 10. Have not received systemic corticosteroid therapy within 4 weeks before treatment, except for physiological corticosteroid replacement therapy; 11. Men with reproductive potential or women with the possibility of pregnancy [without hysterectomy, bilateral oophorectomy, or bilateral tubal ligation, or before menopause (total menopause >= 1 year)], must use a highly effective contraceptive method (eg, oral contraceptives, intrauterine devices, abstinence or barrier contraceptives combined with spermicides) during the trial and continue contraception for 12 months after the end of treatment; 12. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with urothelial adenocarcinoma and other malignant diseases other than urothelial adenocarcinoma within 5 years before the first administration (excluding radically treated basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or radically resected carcinoma in situ); 2. Currently participating in interventional clinical research treatment, or have received other investigational drugs or used investigational device treatment within 4 weeks before the first dose; 3. Have not sufficiently recovered from toxicity and/or complications caused by any intervention (ie, = 2; (3) Any arterial thrombosis, embolism or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, occurred within 6 months before the treatment; (4) Poor blood pressure control (systolic blood pressure>140mmHg, diastolic blood pressure>90mmHg); (5) There is a history of non-infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there is currently clinically active interstitial lung disease; (6) Active pulmonary tuberculosis; (7) There is an active or uncontrolled infection that requires systemic treatment; (8) Clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction; (9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; (10) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol/L); (11) Urine routine indicates urine protein >=++, and confirmed 24-hour urine protein quantitative >1.0g; (12) Patients with mental disorders and unable to cooperate with treatment; (13) Received allogeneic hematopoietic stem cell transplantation in the past; (14) Received other antibody-conjugated drug therapy in the past; 9. Abnormal medical history or disease evidence, treatment or laboratory test values that may interfere with the test results, prevent subjects from participating in the research throughout the study, or the researcher considers other situations that are not suitable for inclusion, or the researcher believes that there are other potential risks and are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactGuo Gang
The Third Medical Center of PLA General Hospital
Outcome results
None listed