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

Xuzhou Medical University

Status and phase: Unknown; Phase 2

Conditions: Uterine Cervical Neoplasms; Sintilimab

Treatments: Drug: Sintilimab; Radiation: External Beam Radiotherapy (EBRT); Radiation: brachytherapy; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05105672

CIBI308XZH

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

chemoradiotherapy + Sintilimab

Experimental group

Description:

Participants will be given intravenous administration of sintilimab (200mg, q3w), cisplatin(75 mg/m², q3w) and Radiotherapy. After completing 2 cycles of concurrent chemoradiation, the Participants will continue to use 4 cycles of sintilimab (200mg, q3w) and cisplatin(75 mg/m², q3w) as maintenance therapy.

Treatment:

Drug: Sintilimab

Radiation: brachytherapy

Drug: Cisplatin

Radiation: External Beam Radiotherapy (EBRT)