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New treatment option for Endometrial Cancer
Official title TQB2450 Plus Progestin for Fertility-sparing Treatment in MMRd EC
ClinicalTrials.gov ID: NCT06914297
What this study is testing
What is TQB2450 injection + oral progestin?
TQB2450 injection + oral progestin is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for endometrial cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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)...
- 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...
- , WHFIGO 2023 IA1-IA2;
You likely can't join if
- and can be followed up regularly in this hospital. Exclusion Criteria:
- Endometrioid carcinoma FIGO grade G3, type II EC (including serous carcinoma, clear cell carcinoma, carcinosarcoma, undifferentiated carcinoma...
- Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases.
- History of important organ transplantation;
- Uncontrolled diseases or active infections;
- Concomitant with severe acute diseases such as stroke, myocardial infarction, etc.
See the full eligibility criteria
- 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...
- 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...
- , 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.
- and can be followed up regularly in this hospital. Exclusion Criteria:
- Endometrioid carcinoma FIGO grade G3, type II EC (including serous carcinoma, clear cell carcinoma, carcinosarcoma, undifferentiated carcinoma, dedifferentiated carcinoma, neuroendocrine carcinoma, etc.), or other...
- Imaging evaluation indicates deep myometrial involvement, cervical involvement, or the possibility of extrauterine metastases.
- History of important organ transplantation;
- Uncontrolled diseases or active infections;
- Concomitant with severe acute diseases such as stroke, myocardial infarction, etc.
- Other malignant tumors of the reproductive system (except in patients with Lynch syndrome who also have ovarian cancer).
- Those who require hysterectomy or other methods of treatment other than conservative medication.
- Pregnant persons;
- 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;
- Smoking history, those who smoke more than 15 cigarettes per day;
- Those who are contraindicated in the use of immunosuppressants or progesterone.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.