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Clinical Trials in China / NCT06548763
Starting soon Phase 2

Oral Topotecan With Toripalimab for Patients With Endometrial Cancer

NCT06548763 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Phase 2
Started
2024-11-30
Last updated
2024-08-12

Condition(s) studied

Endometrial Cancer

Investigational drug(s) / intervention(s)

Topotecan →Toripalimab →

Topotecan: 1.4mg/㎡, orally administered, d1-5

Toripalimab: 240mg, intravenous drip, d1, q3w

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Fudan university shanghai cancer center, Deparment of gynecologic oncology Shanghai Shanghai Municipality

More Fudan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06548763 on ClinicalTrials.gov ↗ ← All trials in China