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Phase II clinical study of sintilimab combined with bevacizumab in the treatment of recurrent or metastatic endometrial cancer with chemotherapy progression or intolerance

Phase II clinical study of sintilimab combined with bevacizumab in the treatment of recurrent or metastatic endometrial cancer with chemotherapy progression or intolerance

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100051023
Enrollment
Unknown
Registered
2021-09-10
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-05-16

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

Conditions

Endometrial cancer

Interventions

single group:sintilimab combined with bevacizumab

Sponsors

Foshan First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Metastatic or locally advanced unresectable endometrial carcinoma in women aged 18 and over; 2. Patients have tumor specimens (formalin fixed, paraffin embedded or fresh pretreated recurrent tumor tissue), which can be used to detect the expression of PD-L1; 3. Radiotherapy and chemotherapy are allowed for neoadjuvant or adjuvant stage 4. According to the recurrence and metastasis, patients can accept the progress of first-line chemotherapy or patients are intolerant to chemotherapy; 5. At least one measurable lesion; 6. ECoG PS: 0-1 point; 7. Estimated survival >= 12 weeks; 8. No serious damage to bone marrow, liver and kidney function; 9. Women of childbearing age without hysterectomy must have taken reliable contraceptive measures, or have conducted pregnancy test (serum or urine) within 7 days before enrollment, and the result is negative, and are willing to use appropriate contraceptive methods during the test and 8 weeks after the last administration of the test drug; 10. The subjects volunteered to join the study, with good compliance and follow-up.

Exclusion criteria

Exclusion criteria: 1. Previously received second-line or above systematic treatment for advanced endometrial cancer; 2.Untreated central nervous system diseases (patients with asymptomatic central nervous system metastasis are allowed); 3. Previous history of autoimmune diseases; 4.Antibody positive for acute or chronic active hepatitis B or acute or chronic active hepatitis C; 5. Have been treated with immune checkpoint inhibitors; 6. Received systemic glucocorticoid or immunosuppressive therapy in the last 4 weeks; 7. Any serious underlying disease, complications and active infection; 8. Receiving other anti-tumor treatment.

Design outcomes

Primary

MeasureTime frame
progression-free survival time;overall survival time;objective response rate;

Countries

China

Contacts

Public ContactXie Yong

Foshan First People's Hospital

diana1007@126.com+86 13600302255

Outcome results

None listed

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