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RECRUITING

NCT06914297

PHASE2

TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC

Sponsor: Fudan University

View on ClinicalTrials.gov

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 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.

Official title: Immune Checkpoint Inhibitors Combined With Progestins for Fertility-sparing Treatment in Patients With MMRd Endometrial Cancer: a Multicenter Single-arm Prospective Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-21

Completion Date

2029-04-01

Last Updated

2025-04-30

Healthy Volunteers

Conditions

Endometrial Cancer

Interventions

DRUG

TQB2450 injection + oral progestin

TQB2450 (1200 mg q3w ivgtt) + megestrol acetate (MA, 160 mg qd po)/megestrol acetate (MPA, 500 mg qd po)

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.

Locations (1)

Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, China