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

Uterine Cervical Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05105672
• Other study ID #: CIBI308XZH
• Status: Recruiting
• Phase: Phase 2
• Start date: March 8, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: December 2021
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: Longzhen Zhang, MD
• Phone: 15895236960
• Email: jsxyfyzlz[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sintilimab
• Uterine Cervical Neoplasms

Intervention

Drug:
• Sintilimab
IV infusion
• Cisplatin
IV infusion

Radiation:
• External Beam Radiotherapy (EBRT)
Undergo pelvic EBRT
• brachytherapy
brachytherapy

Locations

Country	Name	City	State
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	2 years	Time from diagnosis of disease to disease progression or death due to any cause
Secondary	Overall survival	2 years	Time from diagnosis of disease of treatment until death due to any cause
Secondary	Incidence of ADRs and tolerance		1 years