A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer

• Status: Recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: Female

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.

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

Details

• Lead Sponsor: The Affiliated Hospital of Xuzhou Medical University
• Treatments: Cisplatin

Criteria

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/μl; ANC > 1.5 × 10^9/L;Platelets > 100 × 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