Clinical trial · Interventional
Programmed Death-1(PD-1) Inhibitor Combined With Progesterone Treatment in Endometrial Cancer
PD-1 Inhibitor Combined With Progesterone Treatment in Early Stage Endometrial Cancer Patients Who Want to Preserve Fertility
NCT04046185CI-TRIAL-00039892ECCTunknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We want to make a comparison of PD-1 inhibitor combined with progesterone versus progesterone alone in the treatment of early stage endometrial cancer patients who want to preserve fertility.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer Stage I | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PD-1 inhibitor combined progesterone | Drug | — | UNRESOLVED |
| progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- pd-1 inhibitor and progesterone
- description
- Toripalimab. 240mg intravenous injection, every 3 weeks, 4 times. Megestrol Acetate Tablets, 160mg, po, once a day.
- interventionNames
- Drug: PD-1 inhibitor combined progesterone
- type
- ACTIVE_COMPARATOR
- label
- progesterone
- description
- Megestrol Acetate Tablets, 160mg, po, once a day.
- interventionNames
- Drug: progesterone
Primary outcomes (2)
- measure
- Pathologic complete remission rate of endometrial curettage tissues
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Early endometrial cancer patients (cancer confined in the endometrium, endometrioid histology, G1-2) 2. Patients want to preserve fertility 3. Informed consent acquired 4. Age \<18, \>= 45 5. Eastern Cooperative Oncology Group (ECOG) performance status score \<=1 6. Normal blood routine test 7. Normal hepatic and renal function 8. Normal thyroid function 9. Patients willing to accept three times of hysteroscopy: before treatment, 3 months after treatment, 6 months after treatment. 10. Pregnancy test negative before treatment Exclusion Criteria: 1. Patients are receiving immune-checkpoint inhibitor therapy 2. Patients need or request to receive other anti-cancer drug treatment such as chemotherapy 3. Patients are allergic to immune-checkpoint inhibitor agents 4. Patients have abnormal blood routine test results or impaired hepatic and renal functions 5. Patients have a history of cardiovascular disease, including severe hypertension, frequent cardiac arrhythmia, history of myocardial infarction 6. Patients have a history of hepatitis B or hepatitis C infection, with detectable virus load 7. Severe obstructive lung disease 8. Autoimmune disease 9. Need to receive daily corticosteroid or other immune-inhibitory agents 10. Active tuberculosis patients 11. Patients have a history of other malignant tumors 12. Patients with acute infectious disease
References
Publications (0)
Data not yet available
No reference posted for this study.