Status:
UNKNOWN
Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
Lead Sponsor:
Lei Li
Conditions:
Recurrent Cervical Carcinoma
Metastatic Cervical Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 27 2024
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT05310383
Start Date
March 27 2022
End Date
March 27 2024
Last Update
April 11 2022
Active Locations (1)
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1
Lei Li
Beijing, Beijing Municipality, China, 100730