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

NCT05105672UNKNOWNPHASE2INTERVENTIONAL

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.

Key Facts

Lead Sponsor

The Affiliated Hospital of Xuzhou Medical University

Enrollment

Start Date

2021-03-08

Completion Date

2023-03-01

Study Type

INTERVENTIONAL

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

Interventions

SintilimabCisplatinExternal Beam Radiotherapy (EBRT)brachytherapy

Conditions

Uterine Cervical NeoplasmsSintilimab

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

Progression free survival

2 years

Time frame: Time from diagnosis of disease to disease progression or death due to any cause

Overall survival

2 years

Time frame: Time from diagnosis of disease of treatment until death due to any cause

Incidence of ADRs and tolerance

Time frame: 1 years

Locations

The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.