Status:
RECRUITING
TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC
Lead Sponsor:
Fudan University
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
Based on the above situation, the investigators propose the following scientific hypothesis: In young patients with early MMRd type EC, the use of immune checkpoint inhibitors combined with progestero...
Detailed Description
The incidence of endometrial cancer (EC) is on the rise and tends to be younger. With the release of China's multi-child policy and the delay of marriage and childbearing age in modern society, many e...
Eligibility Criteria
Inclusion
- Age range from 18 to 45 years.
- Pathological diagnosis of endometrioid carcinoma by biopsy, diagnostic curettage or hysteroscopy, non-invasive (G1-2); clinical diagnosis by G1-2); clinical diagnosis confirmed by at least two associate senior physicians;
- Run possible, unknown EC;
- Intense MRI, enhanced MMRI, enhanced MRI/CT, and pulmonary CT, or PET/CT assessments indicated that the lesions were limited to the endometrial layer or superficial myometrium, and there was no clear deep myometrium, cervix, or extrauterine involvement.
- , WHFIGO 2023 IA1-IA2;
- EC molecular typing, resulting in MMRd type (molecular typing is based on the World Health Organization (WHO) classification criteria for female genital tumors (5th edition) );
- Those who require or insist on preserving reproductive function, or those who insist on preserving the uterus despite having no fertility requirements.
- informed
- The hospital was followed up on schedule. 2. Exclusion criteria
- and can be followed up regularly in this hospital.
Exclusion
- Endometrioid carcinoma FIGO grade G3, type II EC (including serous carcinoma, clear cell carcinoma, carcinosarcoma, undifferentiated carcinoma, dedifferentiated carcinoma, neuroendocrine carcinoma, etc.), or other non-epithelial uterine malignancies (adenosarcoma, stromal sarcoma, etc.);
- Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases.
- History of important organ transplantation;
- Uncontrolled diseases or active infections;
- Concomitant with severe acute diseases such as stroke, myocardial infarction, etc.
- Other malignant tumors of the reproductive system (except in patients with Lynch syndrome who also have ovarian cancer).
- Those who require hysterectomy or other methods of treatment other than conservative medication.
- Pregnant persons;
- Those who have received conservative treatment (or medication maintenance treatment) with high-potency progesterone or oral contraceptives for more than 1 month due to endometrial hyperplasia in the past three months;
- Smoking history, those who smoke more than 15 cigarettes per day;
- Those who are contraindicated in the use of immunosuppressants or progesterone.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06914297
Start Date
April 21 2025
End Date
April 1 2029
Last Update
April 30 2025
Active Locations (1)
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1
Tenth People's Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200072