A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
NCT ID: NCT05105672
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2021-03-08
2024-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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chemoradiotherapy + 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.
Sintilimab
IV infusion
Cisplatin
IV infusion
External Beam Radiotherapy (EBRT)
Undergo pelvic EBRT
brachytherapy
brachytherapy
Interventions
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Sintilimab
IV infusion
Cisplatin
IV infusion
External Beam Radiotherapy (EBRT)
Undergo pelvic EBRT
brachytherapy
brachytherapy
Eligibility Criteria
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Inclusion Criteria
* 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 a known history of Human Immunodeficiency Virus (HIV) infection.
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years
18 Years
FEMALE
No
Sponsors
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The Affiliated Hospital of Xuzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Longzhen Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Hospital of Xuzhou Medical University
Locations
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The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoxiao Liu, MD
Role: primary
Other Identifiers
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CIBI308XZH
Identifier Type: -
Identifier Source: org_study_id