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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05105672

Enrollment

Registered

2021-11-03

Start date

2021-03-08

Completion date

2024-03-01

Last updated

2021-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms, Sintilimab

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.

Interventions

DRUGSintilimab

IV infusion

DRUGCisplatin

IV infusion

RADIATIONExternal Beam Radiotherapy (EBRT)

Undergo pelvic EBRT

RADIATIONbrachytherapy

brachytherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

China

Contacts

Primary ContactLongzhen Zhang, MD

jsxyfyzlz@126.com15895236960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026