A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
Phase 2
- Conditions
- SintilimabUterine Cervical Neoplasms
- Interventions
- Registration Number
- NCT05105672
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description chemoradiotherapy + Sintilimab External Beam Radiotherapy (EBRT) 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. chemoradiotherapy + Sintilimab brachytherapy 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. chemoradiotherapy + Sintilimab Sintilimab 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. chemoradiotherapy + Sintilimab Cisplatin 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.
- Primary Outcome Measures
Name Time Method Overall response rate 1 year The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
- Secondary Outcome Measures
Name Time Method Progression free survival Time from diagnosis of disease to disease progression or death due to any cause 2 years
Overall survival Time from diagnosis of disease of treatment until death due to any cause 2 years
Incidence of ADRs and tolerance 1 years
Trial Locations
- Locations (1)
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China