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Trial Title:
Oral Topotecan With Toripalimab for Patients With Endometrial Cancer
NCT ID:
NCT06548763
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Topotecan
Conditions: Keywords:
Endometrial Cancer
Topotecan
Toripalimab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Topotecan
Description:
1.4mg/㎡, orally administered, d1-5
Arm group label:
Topotecanwith Terriptylimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
240mg, intravenous drip, d1, q3w
Arm group label:
Topotecanwith Terriptylimab
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.
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.
2. Experimental observation indicators 1) Main indicators: progression-free survival
(PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR),
adverse reactions, changes in immune-related factors and biomarkers
3. Sample size calculation This clinical trial aims to evaluate the safety and efficacy
of oral topotecan combined with toripalimab in treating advanced/recurrent
endometrial cancer patients. Based on literature reports, the median PFS of patients
with advanced/recurrent endometrial cancer is 3.8 months. In comparison, the
experimental group is expected to have a median PFS of 7 months, with an alpha value
of 0.05. Follow-up for 1 year is conducted, considering a 10% dropout rate. This
study plans to include 30 patients with advanced/recurrent endometrial cancer.
Mid-term analysis: Expected ORR not less than 15%, with a minimum of 19 enrolled
cases for mid-term analysis (at least 3 cases of CR or PR)
4. Methods Topotecan, 1.4mg/㎡, orally administered, d1-5+toripalimab 240mg, intravenous
drip, d1, q3w, until disease progression or toxicity intolerance.
5. Data Processing Enter data and use SPSS statistical software for statistical
analysis. Statistical analyst: Clinical Statistics Department of Fudan University
Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Address:
City:
Shanghai
Zip:
200032
Country:
China
Start date:
November 30, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06548763
