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

Sponsor

The Affiliated Hospital of Xuzhou Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05105672

Collaborator

(none)

Enrollment

Location

Arm

35.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms Sintilimab	Drug: Sintilimab Drug: Cisplatin Radiation: External Beam Radiotherapy (EBRT) Radiation: brachytherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 8, 2021

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Sintilimab IV infusion Drug: Cisplatin IV infusion Radiation: External Beam Radiotherapy (EBRT) Undergo pelvic EBRT Radiation: brachytherapy brachytherapy

Arm

Intervention/Treatment

Experimental: 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.

Drug: Sintilimab

IV infusion

Drug: Cisplatin

IV infusion

Radiation: External Beam Radiotherapy (EBRT)

Undergo pelvic EBRT

Radiation: brachytherapy

brachytherapy

Outcome Measures

Primary Outcome Measures

Overall response rate [1 year]
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 [Time from diagnosis of disease to disease progression or death due to any cause]
2 years
Overall survival [Time from diagnosis of disease of treatment until death due to any cause]
2 years
Incidence of ADRs and tolerance [1 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu	China

Sponsors and Collaborators

The Affiliated Hospital of Xuzhou Medical University

Investigators

Principal Investigator: Longzhen Zhang, MD, The Affiliated Hospital of Xuzhou Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Affiliated Hospital of Xuzhou Medical University

ClinicalTrials.gov Identifier:

NCT05105672

Other Study ID Numbers:

CIBI308XZH

First Posted:

Nov 3, 2021

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Cervical Neoplasms

Cisplatin

Study Results

No Results Posted as of Dec 28, 2021