NCT05105672

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 3, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

December 28, 2021

Status Verified

December 1, 2021

Enrollment Period

2 years

First QC Date

October 25, 2021

Last Update Submit

December 24, 2021

Conditions

Uterine Cervical NeoplasmsSintilimab

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Progression free survival

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

  • Overall survival

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

  • Incidence of ADRs and tolerance

    1 years

Study Arms (1)

chemoradiotherapy + Sintilimab

EXPERIMENTAL

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: SintilimabDrug: CisplatinRadiation: External Beam Radiotherapy (EBRT)Radiation: brachytherapy

Interventions

SintilimabDRUG

IV infusion

chemoradiotherapy + Sintilimab
CisplatinDRUG

IV infusion

chemoradiotherapy + Sintilimab
External Beam Radiotherapy (EBRT)RADIATION

Undergo pelvic EBRT

chemoradiotherapy + Sintilimab
brachytherapyRADIATION

brachytherapy

chemoradiotherapy + Sintilimab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

sintilimabCisplatinBrachytherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapyTherapeutics

Study Officials

  • Longzhen Zhang, MD

    The Affiliated Hospital of Xuzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Longzhen Zhang, MD

CONTACT

15895236960jsxyfyzlz@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 3, 2021

Study Start

March 8, 2021

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

December 28, 2021

Record last verified: 2021-12

Locations

CN(1)