NCT05084677

Brief Summary

To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients 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
96

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 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

January 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 18, 2024

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

October 7, 2021

Last Update Submit

January 16, 2024

Conditions

Cervical Cancer

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 (2)

  • Progression free survival

    2 years

  • Overall survival

    3 years

Study Arms (1)

PD-1 arm

EXPERIMENTAL

PD-1 concurrent with and subsequent after concurrent chemoradiotherapy

Combination Product: Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy

Interventions

Toripalimab Combined With Concurrent Platinum-based ChemoradiotherapyCOMBINATION_PRODUCT

Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) concurrent with chemoradiotherapy; 6 cycles of Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) after chemoradiotherapy; Toripalimab 240mg intravenously(IV) every 6 weeks (Q6W) thereafter until the whole treatment period reached one year since the beginning.

PD-1 arm

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75;
  • Untreated patients with pathologically proven locally advanced cervical cancer;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  • Adequate hematological, renal and hepatic functions:
  • Hemoglobin \> 8.0 g/dl
  • Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L
  • Platelets \> 100 × 109/L
  • g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. Serum Total bilirubin ≤ 1.5× UNL
  • Life expectancy \> 6 months
  • Eligible for concurrent chemoradiotherapy assessed by principle investigator;
  • No obvious active bleeding;
  • Written informed consent must be available before study registration

You may not qualify if:

  • Recurrent or distant metastatic disease;
  • Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
  • Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
  • Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
  • Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
  • Previous organ transplantation or HIV patients;
  • Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
  • Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute&Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (1)

  • Chen J, Li C, Cao Y, Zhu L, Zhang B, You J, Hou H, Wang J, Yuan Z. Toripalimab combined with concurrent platinum-based Chemoradiotherapy in patients with locally advanced cervical Cancer: an open-label, single-arm, phase II trial. BMC Cancer. 2022 Jul 19;22(1):793. doi: 10.1186/s12885-022-09866-w.

    PMID: 35854236DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jie Chen

CONTACT

+86-18622221202tjcjvip@126.com

Chen Li

CONTACT

+86-15510932601771016127@qq.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 7, 2021

First Posted

October 20, 2021

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

January 18, 2024

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)