Using TQB2450 and progestin to treat early endometrial cancer while preserving fertility
Immune Checkpoint Inhibitors Combined With Progestins for Fertility-sparing Treatment in Patients With MMRd Endometrial Cancer: a Multicenter Single-arm Prospective Clinical Trial
This study is testing if a new combination of an immune therapy and progesterone can effectively treat early endometrial cancer in young women who want to keep their ability to have children.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | pembrolizumab, Nivolumab, dostarlimab, avelumab, pabolizumab, dotalizumab, sintilizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06914297 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of combining the immune checkpoint inhibitor TQB2450 with high-potency progesterone for treating young patients with early-stage endometrial cancer (EC) who wish to preserve their fertility. The study focuses on patients with MMRd type EC, specifically those with tumors limited to the endometrial layer or superficial myometrium. Participants will receive TQB2450 via intravenous drip and daily oral progesterone, with therapeutic efficacy evaluated through hysteroscopy every 12 weeks. The primary goal is to assess the complete response rate at 12 weeks, while secondary endpoints include longer-term response rates and pregnancy outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 45 with early-stage MMRd endometrial cancer who wish to preserve their reproductive function.
Not a fit: Patients with advanced endometrial cancer or those who do not wish to preserve fertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could allow young women with endometrial cancer to retain their fertility while effectively managing their cancer.
How similar studies have performed: While there have been studies on fertility-sparing treatments for endometrial cancer, the combination of TQB2450 and progestin represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age range from 18 to 45 years. 2. 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; 3. Run possible, unknown EC; 4. 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. 5. , WHFIGO 2023 IA1-IA2; 6. 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) ); 7. Those who require or insist on preserving reproductive function, or those who insist on preserving the uterus despite having no fertility requirements. informed 8. The hospital was followed up on schedule. 2. Exclusion criteria 9. and can be followed up regularly in this hospital. Exclusion Criteria: 1. 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.); 2. Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases. 3. History of important organ transplantation; 4. Uncontrolled diseases or active infections; 5. Concomitant with severe acute diseases such as stroke, myocardial infarction, etc. 6. Other malignant tumors of the reproductive system (except in patients with Lynch syndrome who also have ovarian cancer). 7. Those who require hysterectomy or other methods of treatment other than conservative medication. 8. Pregnant persons; 9. 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; 10. Smoking history, those who smoke more than 15 cigarettes per day; 11. Those who are contraindicated in the use of immunosuppressants or progesterone.
Where this trial is running
Shanghai, Shanghai Municipality
- Tenth People's Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaojun Chen, Ph.D, M.D
- Email: cxjlhjj@163.com
- Phone: 862133189900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.