Tests TQB2450 with progestin to preserve fertility in endometrial cancer
Tests TQB2450 with progestin in young women with early endometrial cancer.
Plain-language title generated from the registry record
Registry title: TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young women with early endometrial cancer of the MMRd type who want to keep their ability to have children or keep their uterus. They would get TQB2450 by drip plus a progestin by mouth.
- Age
- 18 to 45 years
- Sex
- Women
- Disease stage
- Endometrioid carcinoma, non-invasive (G1-2), FIGO 2023 stage IA1-IA2, limited to the endometrium or the outer part of the uterine muscle layer, with no spread to the deep muscle layer, cervix or outside the uterus
- Earlier treatment
- No more than 1 month of high-dose progestin or oral contraceptive treatment for endometrial hyperplasia in the past three months
- Biomarker or test result
- MMRd type on molecular typing of the cancer
Main reasons for not taking part
- Grade G3 endometrioid cancer, type II endometrial cancer or other non-epithelial uterine cancers
- Deep muscle layer, cervix or outside-the-uterus spread suspected on imaging
- History of important organ transplantation
- Pregnancy
- Smoking more than 15 cigarettes per day
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06914297, who can take part
Where in China
- Tenth People's Hospital of Tongji UniversityShanghai, ChinaContact: Yu XueTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fudan University
- Trial code
- NCT06914297
- Record updated
- 4 June 2026
- Original description
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 progesterone for fertility retention therapy can improve the therapeutic efficacy, reduce recurrence, and improve tumor prognosis.Read full original descriptionShow less
Immune Checkpoint Inhibitors Combined With Progestins for Fertility-sparing Treatment in Patients With MMRd Endometrial Cancer: a Multicenter Single-arm Prospective Clinical Trial
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 progesterone for fertility retention therapy can improve the therapeutic efficacy, reduce recurrence, and improve tumor prognosis.
Based on the above assumptions, this project intends to conduct a prospective exploratory clinical study in EC patients limited to the endometrial layer or superficial myometrium (FIGO 2023 IA1-IA2 stage). The subjects were treated with TQB2450 periodic intravenous drip + high-potency progesterone daily oral therapy. During the treatment period, hysteroscopy was performed every 12 weeks to evaluate the therapeutic efficacy. The primary endpoint was the 12-week CR rate; the secondary endpoints included the 24-week CR rate, the 36-week CR rate, the median CR time, the 1-year relapse rate, the 2-year relapse rate, the median relapse time, the pregnancy rate, the live birth rate, and drug-related adverse reactions. The exploratory indicators were the response of different MMRd tumors to immune checkpoint inhibitors and their possible mechanisms. The development of this study will provide a clinical basis for improving the fertility-preserving treatment regimen of MMRd EC.
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: Concomitant with severe acute diseases such as stroke, myocardial infarction, etc; Those who require hysterectomy or other methods of treatment other than conservative medication; 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; 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.); History of important organ transplantation; Uncontrolled diseases or active infections; Other malignant tumors of the reproductive system (except in patients with Lynch syndrome who also have ovarian cancer); Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases; Pregnant persons; Smoking history, those who smoke more than 15 cigarettes per day; Those who are contraindicated in the use of immunosuppressants or progesterone.