A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervica… (NCT05105672) | Clinical Trial Compass
UnknownPhase 2
A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
China20 participantsStarted 2021-03-08
Plain-language summary
This is a single-arm, single-center phase II clinical study to explore the efficacy and safety of sintilimab combined with concurrent chemoradiation therapy as treatment in women with locally advanced cervical cancer.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Has high-risk locally advanced cervical cancer (LACC): The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stage IB3 or FIGO 2018 Stages IIA2-IVA.
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1
* Adequate hematological, renal and hepatic functions:Hemoglobin \> 9.0 g/dl; Neutrophils \> 2000 cells/ÎĽl; ANC \> 1.5 Ă— 10\^9/L;Platelets \> 100 Ă— 10\^9/L;
Exclusion Criteria:
* Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
* Has a known history of Human Immunodeficiency Virus (HIV) infection.
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years
What they're measuring
1
Overall response rate
Timeframe: 1 year
Trial details
NCT IDNCT05105672
SponsorThe Affiliated Hospital of Xuzhou Medical University