NCT06548763

Oral Topotecan With Toripalimab for Patients With Endometrial Cancer

Oral Topotecan in Combination With Toripalimab for Patients With Advanced/Recurrent Endometrial Cancer: a Phase II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the safety and efficacy of oral topotecan combined with toripalimab in treating advanced/recurrent endometrial cancer through a single-center, prospective, single-arm, phase II clinical trial. The goal is to explore the first-line treatment options for endometrial cancer patients in the era of immunotherapy, to improve the overall treatment level and prognosis of endometrial cancer.

Detailed description

1. Overall Design This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of oral topotecan combined with toripalimab in treating advanced/recurrent endometrial cancer. 2. Experimental observation indicators 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), adverse reactions, changes in immune-related factors and biomarkers 3. Sample size calculation This clinical trial aims to evaluate the safety and efficacy of oral topotecan combined with toripalimab in treating advanced/recurrent endometrial cancer patients. Based on literature reports, the median PFS of patients with advanced/recurrent endometrial cancer is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Follow-up for 1 year is conducted, considering a 10% dropout rate. This study plans to include 30 patients with advanced/recurrent endometrial cancer. Mid-term analysis: Expected ORR not less than 15%, with a minimum of 19 enrolled cases for mid-term analysis (at least 3 cases of CR or PR) 4. Methods Topotecan, 1.4mg/㎡, orally administered, d1-5+toripalimab 240mg, intravenous drip, d1, q3w, until disease progression or toxicity intolerance. 5. Data Processing Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Topotecan	1.4mg/㎡, orally administered, d1-5
DRUG	Toripalimab	240mg, intravenous drip, d1, q3w

Timeline

• Start date: 2024-11-30
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

1 site across 1 country: China