Using TQB2450 and progestin to treat early endometrial cancer while preserving fertility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.