NCT06039891

Nimotuzumab Plus Tislelizumab for Recurrent and Metastatic Cervical Cancer

A Single-arm, Single-center, Prospective, Phase II Study of Nimotuzumab, Tislelizumab Plus Radiotherapy for Recurrent and Metastatic Cervical Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Patients with recurrent or metastatic cervical cancer have very poor prognosis. For eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. Epidermal growth factor receptor (EGFR) is overexpressed in cervical cancer cells, anti-EGFR therapy maybe an ideal target for the treatment of cervical cancer. This study aims to discover the progression-free survival of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor \[EGFR\] IgG1 humanized monoclonal antibody) 、Tislelizumab and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial.

Detailed description

Nimotuzumab, is a humanized antibody recognizing with high affinity the epidermal growthfactor (EGF-R)，has shown promising efficacy and tolerable toxicity in the cervical cancer. In this study, patients with recurrent or metastatic cervical cancer, will be included in this study according to the prescribed criteria in the protocal. Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication. Assess objective response rate; progression-free survival; median overall survival and safety ( adverse event).

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Nimotuzumab、Tislelizumab	Subjects will receive Nimotuzumab 400 mg/time, intravenous injection, qw; Tislelizumab 200 mg/time, q3w until disease progression, intolerable toxicity, or 24 months of medication

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2027-10-01
• First posted: 2023-09-15
• Last updated: 2023-09-15