NCT05760053

Toripalimab Plus Etoposide and Platinum-based Chemotherapy for Genitourinary Small Cell Carcinoma

Toripalimab Plus Etoposide and Platinum-based Chemotherapy in First-line Treatment of Locally Advanced or Metastatic Genitourinary Small Cell Carcinoma：A Multicenter, Prospective, Open Label, Single-arm, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, open-label, single-arm phase II clinical trial. A single-arm experimental group of toripalimab, etoposide, and cisplatin/carboplatin was designed to evaluate its efficacy and safety in small cell carcinoma of the urinary system.

Detailed description

This study focuses on patients with locally advanced/metastatic genitourinary small cell carcinoma (small cell carcinoma originating in the kidney, ureter, bladder, urethra, and prostate), and it aims to explore the efficacy and safety of toripalimab combined with EP or EC. After meeting the enrollment conditions, they received combination therapy: toripalimab 240 mg, administered on the first day of each cycle, and a cycle of administration every 3 weeks. Etoposide 100mg/m2, d1-3, cisplatin 25mg/m2, d1-3 or carboplatin AUC=5 d1, administered on the first day of each cycle, a cycle of administration every 3 weeks. Toripalimab combined with etoposide and cisplatin/carboplatin was used for 4 to 6 courses of treatment. Evaluate the curative effect with imaging every 2 courses. If there is an opportunity for local treatment after chemotherapy, participate in multidisciplinary discussions to decide the next step of treatment. For patients who can be treated with local treatment (surgery, radiotherapy) after treatment, the investigator will receive maintenance treatment with toripalimab 240 mg/time, every 21 days, until the disease progresses or unacceptable toxicity occurs. If the curative effect evaluation of the patient is complete remission (CR), partial remission (PR) or stable disease (SD) after 4 to 6 courses of treatment, maintenance therapy with toripalimab 240mg/time, every 21 days, until the disease progression or intolerable toxicity. The maximum duration of maintenance treatment is 2 years. Subjects who finished treatment entered the follow-up period and received safety follow-up and survival follow-up.

Conditions

• Toripalimab
• First-line Treatment

Interventions

Type	Name	Description
DRUG	EP/EC+PD-1	Toripalimab 240 mg, administered on the first day of each cycle, and a cycle of administration every 3 weeks. Etoposide 100mg/m2, d1-3, cisplatin 25mg/m2, d1-3 or carboplatin AUC=5 d1, administered on the first day of each cycle, a cycle of administration every 3 weeks. Toripalimab combined with etoposide and cisplatin/carboplatin was used for 4 to 6 courses of treatment.

Timeline

• Start date: 2023-02-18
• Primary completion: 2025-02-18
• Completion: 2026-02-18
• First posted: 2023-03-08
• Last updated: 2023-03-08

Locations

1 site across 1 country: China