Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Transitional Cell

Urinary Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Disitamab vedotin

Immunoconjugates

Immunologic Factors

Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

After completion of all screening activities, patients confirmed to be eligible will enter the study and receive the following treatments.

Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Disitamab Vedotin for Injection,Penpulimab Injection

Tianxin Lin

This study is a one-arm exploratory clinical study of Disitamab Vedotin for Injection combined with Penpulimab Injection designed for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients.It will confirme the efficacy and safety of Disitamab Vedotin for Injection combined with Penpulimab Injection neoadjuvant treatment for cisplatin intolerant CT2-T4anxm0 bladder urothelial carcinoma patients. Finally, it will provide new evidence-based medical evidence for neoadjuvant therapy for such patients.

This study is a multicenter, open-label, single-arm prospective clinical study to evaluate the neoadjuvant treatment of Disitamab Vedotin for Injection combined with Penpulimab Injection in cisplatin-intolerant cT2-T4aNxM0 bladder urothelial carcinoma Efficacy and safety in patients. If the subject does not withdraw from the trial voluntarily, the toxic and side effects caused by the drug are intolerable, or the investigator believes that the subject is not suitable for further trials, each subject will undergo the following treatment after surgery, and in Efficacy evaluation and follow-up were performed in each cycle.

After completion of all screening activities, patients who are identified as eligible will enter the study and receive the following treatments and visits: Neoadjuvant therapy with Disitamab Vedotin for Injection combined with Penpulimab Injection (administered for a maximum of 4 cycles), every three One week is a medication cycle; patients received radical cystectomy after neoadjuvant chemotherapy; postoperative pathological complete remission rate, downstaging rate, and regular follow-up for two years were evaluated to evaluate the safety of the patients drugs/surgery, and to evaluate the patients new Survival after curative resection with adjuvant immunotherapy combined with chemotherapy.

Neoadjuvant regimen (up to 4 cycles): Disitamab Vedotin for Injection, 2.0 mg/kg, given as an IV infusion on day 1, and Penpulimab Injection, 200 mg, on every 21 days On day 1 of the cycle, it is given as an intravenous infusion. Order of use: Disitamab Vedotin for Injection → Penpulimab Injection.

Surgical plan: radical cystectomy + urinary diversion.

A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma

As assessed by the investigator,proportion of patients without residual tumor lesion among patients who underwent radical cystectomy after completion of clinical trial treatment.

The pathological downstaging rate is judged according to the pathological results after surgery whether the downstaging is below T2 stage.

Safety is evaluated by monitoring and recording all adverse events graded as NCI-CTCAE V5.0 or Clavien-Dindo.

Event-free survival (EFS) is the time from the start of the first neoadjuvant therapy to disease progression, death from any cause, or new development of other tumors.

Overall survival (OS) is defined as the time from the start of treatment to death from any cause.

Spots Global Cancer Trial Database for disitamab vedotin for injection,penpulimab injection