Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084677
• Other study ID #: 202020080608084322319
• Status: Recruiting
• Phase: Phase 2
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Jie Chen
• Phone: +86-18622221202
• Email: tjcjvip[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute&Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival	Time from diagnosis of disease to disease progression or death due to any cause	2 years
Secondary	Overall survival	Time from diagnosis of disease of treatment until death due to any cause	3 years