Endometrial CancerPhase 2NCT06548763
Oral Topotecan With Toripalimab for Patients With Endometrial Cancer
A Phase 2 study testing Topotecan and Toripalimab in people with Endometrial Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Topotecan and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2024to 31 Dec 2026
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- 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;
- Individuals who are known to be allergic, highly sensitive, or intolerant to the active ingredients or other components of the investigational drug;
- Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ and non melanoma skin cancer;
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan university shanghai cancer center, Deparment of gynecologic oncology
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Oral Topotecan in Combination With Toripalimab for Patients With Advanced/Recurrent Endometrial Cancer: a Phase II Clinical Study
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.
Read the detailed description
- 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.
- 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
- 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)
- Methods Topotecan, 1.4mg/㎡, orally administered, d1-5+toripalimab 240mg, intravenous drip, d1, q3w, until disease progression or toxicity intolerance.
- 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.
- Conditions
- Endometrial Cancer
- Being tested
- Topotecan, Toripalimab
- Keywords
- Endometrial Cancer, Topotecan, Toripalimab
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
1.4mg/㎡, orally administered, d1-5
ToripalimabDrug
240mg, intravenous drip, d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Topotecanwith Terriptylimab | Experimental | Oral administration of topotecan and intravenous infusion of trastuzumab until disease progression or toxicity intolerance occurs. Receives: Drug: Topotecan; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression free survival
Measured: Two years
Secondary outcomes (2)
OS
Overall Survival
Measured: Two years
ORR
Overall Remission Rate
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start30 Nov 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaohua Wu MD [zzhong], Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548763
- Sponsor's protocol ID
- ECR-TT-2024
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No