Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
- Conditions
- Objective Response RateRecurrent Cervical CarcinomaRadiotherapyImmune Checkpoint InhibitorsAnti-programmed Cell Death Receptor 1Survival OutcomesMetastatic Cervical CarcinomaPersistent Cervical CarcinomaImmunotherapyTislelizumab
- Interventions
- Combination Product: Tislelizumab plus radiotherapy
- Registration Number
- NCT05310383
- Lead Sponsor
- Lei Li
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 58
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with recurrent cervical cancer Tislelizumab plus radiotherapy Patients with recurrent, metastatic and persistent advanced cervical cancer
- Primary Outcome Measures
Name Time Method Objective Response Rate 12 months Overall survival is defined as the duration from date of enrollment to the date of death from any cause
- Secondary Outcome Measures
Name Time Method Overall survival 24 months Overall survival is defined as the duration from date of enrollment to the date of death from any cause
Progression-free survival (PFS) 12 months PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.
Adverse Events 24 months Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Trial Locations
- Locations (1)
Lei Li
🇨🇳Beijing, Beijing, China