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NCT06548763Not yet recruitingPhase 2

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 · Last updated 12 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (estimated)
First submitted
28 Jul 2024
Start date
30 Nov 2024
Primary completion date
30 Jun 2026
Lead sponsor
Fudan University
NCT number
NCT06548763

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 30
  • From 30 Nov 2024 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals who are known to be allergic, highly sensitive, or intolerant to the active ingredients or other components of the investigational drug;

Other illness

  • 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;
  • Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ and non melanoma skin cancer;

Age

  • 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;

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.