Trial · NCT07319429
Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification
NCT07319429, Phase 2, Phase 3, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification. Trials, record NCT07319429. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07319429
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification
- NCT number
- NCT07319429
- Status
- Recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 260 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Endometrial Cancer, Fertility
- Interventions
- PD1 antibody, Medroxyprogesterone Acetate 500 MG, Megestrol Acetate 160 MG, GnRH agonist and Letrozole
- First posted
- 2026-01-06
- Last updated
- 2026-03-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The complete response rate (CRR) at 32 weeks after initiating treatment. | 32 full weeks following the first administration of fertility-preserving treatment for early-stage endometrial cancer patients. | This endpoint aims to assess the therapeutic response of patients stratified by molecular subtypes ( POLE-mutant, MSI-H, and NSMP). The complete response rate (CRR) is defined as the proportion of patients in each molecular subtype cohort who achieve complete disappearance of all detectable endometrial lesions, confirmed by a combination of hysteroscopic examination and endometrial biopsy (pathologically negative for cancer cells). |
| Secondary | the complete response rate (CRR) at 16 weeks after initiating treatment. | 16 full weeks following the first administration of fertility-preserving treatment for early-stage endometrial cancer patients. | This endpoint aims to assess the 16 weeks' response of patients stratified by molecular subtypes ( POLE-mutant, MSI-H, and NSMP). The complete response rate (CRR) is defined as the proportion of patients in each molecular subtype cohort who achieve complete disappearance of all detectable endometrial lesions, confirmed by a combination of hysteroscopic examination and endometrial biopsy (pathologically negative for cancer cells). |
| Secondary | Median treatment duration to achieve complete response in study cohorts with different molecular subtypes | through study completion, an average of 1 year. | The median duration is calculated using the Kaplan-Meier method, with the start time anchored to the first day of treatment and the end time marked as the date of the pathological report confirming complete response. Patients who do not achieve complete response by the end of the study (32 weeks) or who discontinue treatment early due to progression, adverse events, or personal reasons will be classified as "censored" in the statistical analysis, and their follow-up status will be clearly recorded. |
| Secondary | Adverse Reactions and Safety Profiles of Different Fertility-Preserving Treatment Regimens | Throughout study completion, an average of 1year | Safety is evaluated based on the incidence, severity, and resolution of adverse reactions (ARs) associated with each treatment regimen. ARs are graded according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, including grade 1 (mild) to grade 5 (death). |
| Secondary | Impact of Different Treatment Regimens on Ovarian Function | at four time points: (1) Baseline (within 1 week before treatment initiation); (2) 16 weeks after treatment; (3) 32 weeks after treatment; (4) The time point of complete response (if achieved earlier than 32 weeks). | Specific evaluation indicator: anti-Müllerian hormone (AMH) .The impact of treatment is defined as the relative change in AMH from baseline, with a focus on identifying whether the treatment causes reversible or irreversible damage to ovarian reserve. |
| Secondary | Quality of Life of Patients Receiving Different Treatment Regimens | Assessments are conducted at the same four time points as ovarian function evaluation (baseline, through study completion, an average of 1year). | Quality of life (QoL) is evaluated using validated international scales |
| Secondary | Disease Recurrence Rate Within 2 Years After Achieving Complete Response During Follow-Up | The follow-up period starts from the date of confirmed complete response and lasts for 24 consecutive months. | Recurrence is defined as the re-emergence of endometrial cancer lesions (confirmed by pathology), or the occurrence of extrauterine metastases (e.g., pelvic lymph node, ovarian, or distant organ metastases) confirmed by imaging (MRI/CT/PET-CT) and/or pathology.The recurrence rate is calculated as the number of patients with recurrence divided by the total number of patients who achieved complete response. For patients lost to follow-up, the last follow-up date is used as the censoring time, and the reason for loss to follow-up is recorded. |
| Secondary | Pregnancy Rate within 2 Years After Achieving Complete Response During Follow-Up | starting from the date of complete response and ending at 2 years or the time of the first pregnancy (whichever comes first). | This endpoint focuses on the reproductive potential of patients after successful fertility-preserving treatment, with follow-up starting from the date of complete response and ending at 2 years or the time of the first live birth (whichever comes first). Pregnancy rate: the proportion of patients who achieve clinical pregnancy (confirmed by ultrasound showing intrauterine gestational sac and fetal heartbeat) after natural conception or assisted reproductive technology (ART, e.g., in vitro fertilization-embryo transfer); |
| Secondary | Live birth rate within 2 Years After Achieving Complete Response During Follow-Up | starting from the date of complete response and ending at 2 years or the time of the first live birth (whichever comes first). | Live birth rate: the proportion of patients who deliver a viable infant (born after ≥24 weeks of gestation) among those who achieved clinical pregnancy. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07319429
GET https://conductscience.org/api/trials/v1/NCT07319429/registered