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

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Arm, Single-Center Phase II Clinical Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in The Treatment of Stage IIA2 To IVA (2018 FIGO) Locally Advanced Cervical Cancer

Conditions
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Uterine Cervical Neoplasms, Sintilimab

Intervention / Treatment
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* Drug: Sintilimab
* Drug: Cisplatin
* Radiation: External Beam Radiotherapy (EBRT)
* Radiation: brachytherapy


Participation Criteria
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Eligibility Criteria
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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/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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemoradiotherapy + Sintilimab<br>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. | Drug: Sintilimab<br>* IV infusion<br>Drug: Cisplatin<br>* IV infusion<br>Radiation: External Beam Radiotherapy (EBRT)<br>* Undergo pelvic EBRT<br>Radiation: brachytherapy<br>* brachytherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | 2 years | Time from diagnosis of disease to disease progression or death due to any cause | 
| Overall survival | 2 years | Time from diagnosis of disease of treatment until death due to any cause | 
| Incidence of ADRs and tolerance |  | 1 years |