Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    38
  • sponsor
    Tongji Hospital
Updated on 15 February 2021

Summary

Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicates that both bevacizumab and PD-1 inhibitor have clinical benefit for OCCC patients. And the combination of bevacizumab and PD-1 inhibitor has shown preliminary safety and clinical activity. Therefore, this study aims to investigate the protential benefit of combation therapy for patients with OCCC.

Details
Condition Ovarian Clear Cell Carcinoma
Treatment Sintilimab, Bevacizumab Biosimilar IBI305
Clinical Study IdentifierNCT04735861
SponsorTongji Hospital
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Are you female?
Do you have any of these conditions: Do you have Ovarian Clear Cell Carcinoma??
Recurrent or persistent ovarian clear cell carcinoma with at least one-line pretreated platinum-containing chemotherapy
Histologically diagnosis of ovarian clear cell carcinoma. For tumors with mixed histology, at least 70% of the tumors are composed of clear cell carcinoma
Provide informed consent
ECOG0-2
Aged 18 years and < 75 years
Have one or more measurable lesions by RECIST 1.1 criteria
Expected survival > 12 weeks
Adequate hematology and organ function

Exclusion Criteria

Previous administration of immune checkpoint inhibitors, including anti-PD-1/PD-L1/PD-L2 drugs; or anti stimulating/synergistic inhibition of T cell receptor (for example, CTLA-4, OX-40, CD137) drug
Lack of tumor samples (archived and/or recent obtained)
Patients who have any contraindications of bevacizumab, including but not limited to previous gastrointestinal perforation, receiving surgery or having incomplete-healing wound within 28 days before administration of combination therapy, severe bleeding or recent hemoptysis, and other circumstances that are inappropriate for bevacizumab according to physician's assessment
Patients known to be allergic to the active ingredients or excipients of sintilimab or bevacizumab
Patients diagnosed of other malignant diseases other than ovarian cancer within 5 years before the first administration
Patients have an active autoimmune disease that requires systemic treatment within 2 years before the first administration
Symptomatic or uncontrolled brain metastases that require simultaneous treatment
Have undergone major surgery (craniotomy, thoracotomy or open surgery) or unhealed wounds, ulcers or fractures within 4 weeks
Currently participating in interventional clinical trial, or received other research drugs or used research equipment treatment within 4 weeks before the first administration
Active hemoptysis within 3 months before the first administration
Patients have been vaccinated with live vaccine within 1 month before the first administration
Patients have received platelet or red blood cell transfusion within 4 weeks before the first administration
Patients receive major surgery within 4 weeks before the first administration (except for surgery for the purpose of biopsy) or expect major surgery during the study period
Patient have received anti-tumor or immunomodulatory treatment within 2 weeks before the first administration
Patients are receiving systemic glucocorticoid therapy (not including nasal spray, inhaled or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration
HIV infected (HIV 1/2 antibody positive)
Patients have a hereditary bleeding tendency or coagulation dysfunction, or a history of thrombosis
Severe unhealed wound ulcers or fractures
Known allogeneic organ transplantation (except for corneal transplantation) or allogeneic hematopoietic stem cell transplantation
Untreated active hepatitis B
Women patients who are pregnant or breastfeeding, or expect to become pregnant during the study treatment period
Any severe or uncontrolled systemic diseases
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