RecruitingPhase 2NCT06914297

TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC

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


Sponsor

Fudan University

Enrollment

10 participants

Start Date

Apr 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a fertility-sparing treatment approach — using an immunotherapy drug (TQB2450) combined with hormone therapy (progestin) — for young women with early-stage uterine cancer who want to preserve their ability to have children. **You may be eligible if...** - You are between 18 and 45 years old - You have been diagnosed with early-stage endometrial (uterine lining) cancer, grade 1–2, by biopsy or other procedure - Your cancer is a specific molecular subtype called MMRd (mismatch repair deficient) - Imaging shows the cancer is confined to the inner lining of the uterus with no deep spread - You want to preserve your fertility or uterus **You may NOT be eligible if...** - Your cancer is grade 3 or a more aggressive type (such as serous or clear cell carcinoma) - Imaging suggests the cancer has spread into the uterine muscle wall or outside the uterus - You have had an organ transplant - You are currently pregnant - You have another reproductive system cancer (except for specific cases linked to Lynch syndrome) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2450 injection + oral progestin

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


Locations(1)

Tenth People's Hospital of Tongji University

Shanghai, Shanghai Municipality, China

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NCT06914297


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