A Study of Cadonilimab（AK104）Combined With Standard Treatment for Function Preservation in Urinary System Tumors

Launched by TONGJI HOSPITAL · May 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called cadonilimab, which is being tested in combination with standard care for patients with certain types of urinary system tumors, specifically urothelial carcinoma (bladder cancer) and renal cell carcinoma (kidney cancer). The goal of the study is to see if this treatment can help preserve the function of the bladder and kidneys while effectively treating the cancer. The trial is currently not recruiting participants, but it will involve adults aged 18 and older who have been diagnosed with these types of cancer, have not received prior treatment, and are willing to have surgery to remove the tumor.

To participate, individuals must agree to take part in the study and have a good chance of surviving for at least 12 weeks. They should also have specific high-risk forms of the cancers mentioned. Participants can expect to undergo this new treatment along with standard care, and they will need to attend regular study visits. It's important to note that certain health conditions and recent treatments may prevent some people from joining the trial. Overall, this study aims to find out if cadonilimab can improve treatment outcomes while helping to maintain the organ functions that are crucial for a patient's quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntary agreement to provide written informed consent.
• • Male or female, Age ≥ 18 years.
• • Predicted survival ≥ 12 weeks.
• • Histologically confirmed diagnosis of urothelial carcinoma（UC） and renal cell carcinoma（RCC）.
• • Prior no antitumor systematic treatment .
• • Have clinically non-metastatic high risk urothelial carcinoma (cT2-T4a, N0-3, M0) .
• • High risk renal cell carcinoma (≥ T2Nx or TanyN+)，include subjects with only Oligotransfer.
• • Willing to undergo 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.
• • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
• • Adequate organ function, evidenced by the following laboratory results within 7 days prior to the study treatment.
• • Male and female participants are eligible to participate if they agree to the contraception use as per study protocol.
• • Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
• Exclusion Criteria:
• • Has received other antitumor therapy before planned start of trial treatment.
• • History of major surgery within 4 weeks of planned start of trial treatment.
• • Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
• • Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
• • NYHA Class III heart failure.
• • Suffering from active infection requiring systemic treatment.
• • Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD;
• • Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
• • History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
• • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• • Pregnancy or lactation.
• • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.