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

Primary Purpose

Uterine Cervical Neoplasms, Sintilimab

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Sintilimab
Cisplatin
External Beam Radiotherapy (EBRT)
brachytherapy
Sponsored by
The Affiliated Hospital of Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Cervical Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • The Affiliated Hospital of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemoradiotherapy + Sintilimab

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Progression free survival
2 years
Overall survival
2 years
Incidence of ADRs and tolerance

Full Information

First Posted
October 25, 2021
Last Updated
December 24, 2021
Sponsor
The Affiliated Hospital of Xuzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05105672
Brief Title
A Study of Sintilimab Combined With Concurrent Chemoradiation Therapy in Locally Advanced Cervical Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of Xuzhou Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms, Sintilimab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemoradiotherapy + Sintilimab
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sintilimab
Intervention Description
IV infusion
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
IV infusion
Intervention Type
Radiation
Intervention Name(s)
External Beam Radiotherapy (EBRT)
Intervention Description
Undergo pelvic EBRT
Intervention Type
Radiation
Intervention Name(s)
brachytherapy
Intervention Description
brachytherapy
Primary Outcome Measure Information:
Title
Overall response rate
Description
The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Progression free survival
Description
2 years
Time Frame
Time from diagnosis of disease to disease progression or death due to any cause
Title
Overall survival
Description
2 years
Time Frame
Time from diagnosis of disease of treatment until death due to any cause
Title
Incidence of ADRs and tolerance
Time Frame
1 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Longzhen Zhang, MD
Phone
15895236960
Email
jsxyfyzlz@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Longzhen Zhang, MD
Organizational Affiliation
The Affiliated Hospital of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Liu, MD
Phone
18752113909
Email
281656652@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Liu, MD
First Name & Middle Initial & Last Name & Degree
Longzhen Zhang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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