Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Patients with recurrent cervical cancer Patients with recurrent, metastatic and persistent advanced cervical cancer |
Combination Product: Tislelizumab plus radiotherapy
During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.
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Outcome Measures
Primary Outcome Measures
- 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
- 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.
- Overall survival [24 months]
Overall survival is defined as the duration from date of enrollment to the date of death from any cause
- Adverse Events [24 months]
Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient voluntarily participates and signs informed consent
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Aged 18 years of age or older
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Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 within 7 days prior to the first dose of study treatment
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Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy
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Willing to accept concurrent radiotherapy combined with Tislelizumab
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Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator
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Has adequate organ function
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Has expected survival time ≥3 months
Exclusion Criteria:
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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
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Has a known history of Human Immunodeficiency Virus (HIV) infection,active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)
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Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure
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Has received a major surgery within 4 weeks prior to signing informed consent
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Not suitable for radiotherapy
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Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria
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Did not meet the other requirements for inclusion by the investigator
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Judged unqualified of the enrollment requirements by the researcher according to other conditions
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Lei Li | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Lei Li
Investigators
- Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IMURADIO2