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This is an open label, dual cohort ,phase II study to explore efficacy and safety of cadonilimab(PD-1/CTLA-4 Bispecific Antibody) combined with standard regimen neoadjuvant treatment in urothelial carcinoma(UC) and renal cell carcinoma(RCC), with evaluating successful preservation rate of bladder/kidney.
UC and RCC confirmed by histopathology or cytology prior have not received systematic treatment, who had indications for surgical resection and were difficult to preserve organ function after surgery or were partially resection but the patients have a strong desire to preserve organ function. This study enrolled 20 cases in each cohort of UC and RCC,pts received neoadjuvant treatment containing cadonilimab for no more than 6 cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC | Experimental | Patients will receive AK104 (10mg/kg ,Q3W,intravenously) plus standard regimen (gemcitabine or albumin paclitaxel) neoadjuvant treatment with no more than 6 cycles. |
|
| RCC | Experimental | Patients will receive AK104 (10mg/kg ,Q3W,intravenously) plus standard regimen (TKI,e.g. sunitinib, pezopanib) neoadjuvant treatment with no more than 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cadonilimab plus chemotherapy | Drug | AK104 (10mg/kg ,Q3W,intravenously) plus chemotherapy(e.g. gemcitabine or albumin paclitaxel,dosage based on guidelines or instructions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bladder/Kidney Preservation rate | Evaluating the impact of neoadjuvant therapy on organ preservation function | Up to approximately 18 Weeks (Time of surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | percentage of participants with a complete response (CR) or partial response (PR) | Up to approximately 18 Weeks |
| Rate of Pathologic Response | No residual tumor (ypT0N0) and partial response (ypTis-1N0) in surgical specimen. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Huang, Clinical Professor | Contact | 63639656 | huangliu@tjh.tjmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Liu Huang, Clinical Professor | Tongji Hospital , Wuhan, Hubei Province, China, 430030 | Principal Investigator |
| Xiao Yu, Clinical Professor | Tongji Hospital , Wuhan, Hubei Province, China, 430030 | Principal Investigator |
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| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Cadonilimab plus TKI | Drug | Patients will receive AK104 (10mg/kg ,Q3W,intravenously) plus TKI(e.g. sunitinib, pezopanib,dosage based on guidelines or instructions) |
|
| Up to approximately 18 Weeks (Time of surgery) ] |
| Overall Survival (OS) | Overall survival is defined as the time from enrollment to death due to any cause. | Up to approximately 36 Months |
| Assess Adverse Events | Assess adverse events according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 | 12 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014570 | Urologic Diseases |