Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Topotecan | Drug | Topotecan | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Topotecanwith Terriptylimab
- description
- Oral administration of topotecan and intravenous infusion of trastuzumab until disease progression or toxicity intolerance occurs.
- interventionNames
- Drug: Topotecan
- Drug: Toripalimab
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Two years
- description
- Progression free survival
Secondary outcomes (2)
- measure
- OS
- timeFrame
- Two years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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. 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.
References
Publications (0)
Data not yet available