Status:
NOT_YET_RECRUITING
Oral Topotecan With Toripalimab for Patients With Endometrial Cancer
Lead Sponsor:
Fudan University
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
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/r...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old, female;
- Patients with advanced/recurrent endometrial cancer diagnosed by histopathology and failed first-line treatment;
- Can provide 10 pathological white films for subsequent research;
- Physical fitness status score ECOG ≤ 2;
- Expected survival period ≥ 3 months;
- The subjects can understand the research process, voluntarily participate in this study, sign informed consent forms, have good compliance, and cooperate with follow-up.
Exclusion
- Pregnant and lactating patients, women of childbearing age who refuse to take effective contraceptive measures during the study period; Individuals with peripheral nervous system disorders caused by diseases or those with a history of significant mental and central nervous system disorders;
- Serious or uncontrolled infections that may affect research treatment or evaluation of research results, including but not limited to active hepatitis virus infections, positive human immunodeficiency virus (HIV) antibodies, lung infections, etc;
- Individuals who are known to be allergic, highly sensitive, or intolerant to the active ingredients or other components of the investigational drug;
- Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ and non melanoma skin cancer;
- Patients who are currently participating or have participated in other clinical trials within the past month;
- The researchers determined that the patients were not suitable to participate in this study.
Key Trial Info
Start Date :
November 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06548763
Start Date
November 30 2024
End Date
December 31 2026
Last Update
August 12 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, China, 200032