Tislelizumab and Radiotherapy for Recurrent Cervical Cancer (NCT05310383) | Clinical Trial Compass
UnknownPhase 2
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
China58 participantsStarted 2022-03-27
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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