Oral Topotecan With Toripalimab for Patients With Endometrial Cancer

Phase 2

Not yet recruiting

• Conditions: Endometrial Cancer
• Interventions: Drug: Topotecan; Drug: Toripalimab

• Registration Number: NCT06548763
• Lead Sponsor: Fudan University

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 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 ...

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-28
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12
• Study Start: 2024-11-30
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Age ≥ 18 years old, female;
2. Patients with advanced/recurrent endometrial cancer diagnosed by histopathology and failed first-line treatment;
3. Can provide 10 pathological white films for subsequent research;
4. Physical fitness status score ECOG ≤ 2;
5. Expected survival period ≥ 3 months;
6. The subjects can understand the research process, voluntarily participate in this study, sign informed consent forms, have good compliance, and cooperate with follow-up.

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Exclusion Criteria

1. 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;
2. 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;
3. Individuals who are known to be allergic, highly sensitive, or intolerant to the active ingredients or other components of the investigational drug;
4. Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ and non melanoma skin cancer;
5. Patients who are currently participating or have participated in other clinical trials within the past month;
6. The researchers determined that the patients were not suitable to participate in this study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topotecanwith Terriptylimab	Toripalimab	Oral administration of topotecan and intravenous infusion of trastuzumab until disease progression or toxicity intolerance occurs.
Topotecanwith Terriptylimab	Topotecan	Oral administration of topotecan and intravenous infusion of trastuzumab until disease progression or toxicity intolerance occurs.

Primary Outcome Measures

Name	Time	Method
PFS	Two years	Progression free survival

Secondary Outcome Measures

Name	Time	Method
OS	Two years	Overall Survival
ORR	Two years	Overall Remission Rate

Trial Locations

Locations (1)

Fudan university shanghai cancer center, Deparment of gynecologic oncology; 🇨🇳 Shanghai, Shanghai, China