Sintilimab Plus Bevacizumab in Recurrent/Persistent Ovarian Clear Cell Carcinoma

Sponsor
Tongji Hospital
Study ID
NCT04735861
Phase
PHASE2
Status
Completed

Conditions

  • Ovarian Clear Cell Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Feb 3, 2021
Start date
Apr 7, 2021
Status verified
Aug 2024
Primary completion
Jul 30, 2024
Completion
Jul 30, 2024

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Arm
    Sintilimab 200mg iv., q3w, up to 2 years; Bevacizumab 15mg/kg iv., q3w, up to 22 cycles. Treatment is given until confirmed progression, death, unacceptable toxicity, or any other protocol-specified criterion for withdrawal, whichever occurs first.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 3 years ]

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