Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

January 16, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital

Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial

To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to now, there have been several prospective studies exploring the effectiveness of PD-1 inhibitors in patients with recurrent/ metastatic cervical cancer. The results showed that the overall objective response rate (ORR) was between 12.2% and 55.6%, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. However, the evidence of using PD-1 inhibitors together with concurrent chemotheradiotherapy in patients with locally advanced cervical cancer is rare, so we initiated this single arm prospective phase II clinical study. The purpose is to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute＆Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Hemoglobin > 8.0 g/dl
    2. Neutrophils > 2000 cells/μl; Leukocytes > 4 × 109/L
    3. 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PD-1 arm
PD-1 concurrent with and subsequent after concurrent chemoradiotherapy
Combination product: Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate
Time Frame: 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 2 years
Time from diagnosis of disease to disease progression or death due to any cause
2 years
Overall survival
Time Frame: 3 years
Time from diagnosis of disease of treatment until death due to any cause
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202020080608084322319

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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