Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Recurrent Cervical Carcinoma
- Sponsor
- Lei Li
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Objective Response Rate
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.
Investigators
Lei Li
Professor
Peking Union Medical College Hospital
Eligibility Criteria
Inclusion Criteria
- •The patient voluntarily participates and signs informed consent
- •Aged 18 years of age or older
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
- •Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
- •Willing to accept concurrent radiotherapy combined with Tislelizumab
- •Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
- •Has adequate organ function
- •Has expected survival time ≥3 months
Exclusion Criteria
- •Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
- •Has a known history of Human Immunodeficiency Virus (HIV) infection，active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
- •Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
- •Has received a major surgery within 4 weeks prior to signing informed consent
- •Not suitable for radiotherapy
- •Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
- •Did not meet the other requirements for inclusion by the investigator
- •Judged unqualified of the enrollment requirements by the researcher according to other conditions
Outcomes
Primary Outcomes
Objective Response Rate
Time Frame: 12 months
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Secondary Outcomes
- Overall survival(24 months)
- Progression-free survival (PFS)(12 months)
- Adverse Events(24 months)