Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

Ovarian clear cell carcinoma (OCCC) is one of the rare subtypes of ovarian cancer, yet its prognosis is extremely poor. Previous studies indicate that both bevacizumab and PD-1 inhibitor have clinical benefits 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 potential benefit of combination therapy for patients with OCCC.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji Hospital
• Collaborators: Anhui Provincial Cancer Hospital; Henan Cancer Hospital; Hubei Cancer Hospital; Jingzhou Central Hospital; Qilu Hospital of Shandong University; Shengjing Hospital; The First Affiliated Hospital of Zhengzhou University; The First People's Hospital of Jingzhou; Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; Wuhan University; Xiangyang Central Hospital
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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.

• ECOG：0-2.

• 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.