Toripalimab Combined With Definitive CCRT for LACC Patients

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Immunotherapy; Chemoradiotherapy; Cervical Cancer

Treatments: Radiation: CCRT; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT06256224

2024（022）

Details and patient eligibility

About

Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• more than 18 years old females
• had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix
• FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis
• ECOG PS 0-1 without major organ failure
• signed informed consent voluntarily

Exclusion criteria

• previously suffered from immunodeficiency disorders
• had any condition that researchers believed to be associated with increased risk of treatment
• Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

Toripalimab+CCRT

Experimental group

Description:

External beam radiotherapy (EBRT) of 45-50.4Gy was delivered using intensity modulated radiation therapy (IMRT) technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg/m2 by intravenous infusion, was administered once a week for 5 weeks during EBRT. Toripalimab 240mg by intravenous infusion was administered every 3 weeks for 6 months and maintained upto 2 years for those whose lesions did not reach complete remission at six-month follow-up.

Treatment:

Radiation: CCRT

Drug: Toripalimab

CCRT

Active Comparator group

Description:

EBRT of 45-50.4Gy was delivered using IMRT technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg/m2 by intravenous infusion, was administered once a week for 5 weeks during EBRT.

Treatment:

Radiation: CCRT