Skip to content

Clinical study for PD-1 inhibitor combined with progesterone therapy for early endometrial cancer with preservation of fertility

Clinical study for PD-1 inhibitor combined with progesterone therapy for early endometrial cancer with preservation of fertility

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022898
Enrollment
Unknown
Registered
2019-04-30
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

endometrial cancer

Interventions

experimental group:Triprimab, 240 mg intravenously, 4 times every 3 weeks. At the same time, Yining, 160 mg, once a day
Control group:Yining, oral 160 mg, once a day

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Early stage endometrial cancer patients (tumor is confined to the endometrium, endometrioid carcinoma, G1-2); 2) The patient has a fertility request or is required to retain the uterus due to other factors; 3) Obtain informed consent from patients and are willing to receive relevant treatment and follow-up; 4) Aged 18 to 45 years old; 5) ECOG score = 1; 6) Normal blood test (WBC=4*10^9/L, HB=10g/L, PLT=100*10^9/L); 7) Normal liver and kidney function.

Exclusion criteria

Exclusion criteria: 1) The patient has been or is undergoing immunological checkpoint inhibitor treatment; 2) The patient needs or requires treatment with other anti-tumor drugs (such as chemotherapy drugs) other than progesterone during the test; 3) The patient has a history of allergies to immunological checkpoint inhibitors; 4) The patient has a tendency to easily bleed; 5) Patients with abnormal blood or liver and kidney function; 6) The patient has a history of cardiovascular disease, including severe hypertension, severe arrhythmia, and history of myocardial infarction; 7) The patient has a history of hepatitis B or hepatitis C infection with a detectable viral load; 8) Severe obstructive pulmonary disease; 9) Patients with autoimmune diseases; 10) Those who need corticosteroids or other immunosuppressive agents every day due to other diseases; 11) Active tuberculosis patients; 12) History of other malignant tumors; 13) Patients with acute infection; 14) Vaccinated patients within 30 days.

Design outcomes

Primary

MeasureTime frame
pathologic examination of endometrial;

Countries

China

Contacts

Public ContactXiaoping Wan

Shanghai First Maternity and Infant Hospital

wanxiaoping@tongji.edu.cn+86 021 65982875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026