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Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

Primary Purpose

Cervical Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy

About this trial

This is an interventional treatment trial for Cervical Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Tianjin Medical University Cancer Institute&HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PD-1 arm

Arm Description

PD-1 concurrent with and subsequent after concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05084677

First Posted

October 7, 2021

Last Updated

October 19, 2021

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05084677

Brief Title

Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PD-1 arm

Arm Type

Experimental

Arm Description

PD-1 concurrent with and subsequent after concurrent chemoradiotherapy

Intervention Type

Combination Product

Intervention Name(s)

Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Overall response rate

Description

The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Progression free survival

Description

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

Time Frame

2 years

Title

Overall survival

Description

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

Time Frame

3 years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jie Chen

Phone

+86-18622221202

tjcjvip@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Li

Phone

+86-15510932601

771016127@qq.com

Facility Information:

Facility Name

Tianjin Medical University Cancer Institute&Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Chen

Phone

+86-18622221202

tjcjvip@126.com

First Name & Middle Initial & Last Name & Degree

Chen Li

Phone

+86-15510932601

771016127@qq.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35854236

Citation

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.

Results Reference

derived

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Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

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