Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer
NCT ID: NCT05588219
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2022-12-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental arm
The therapeutic schedule of the experimental arm: External irradiation 45\~50Gy/25f+ Brachytherapy 28\~30Gy/4\~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles; Tislelizumab injection\[10ml:100mg\]: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
Tislelizumab
Tislelizumab injection\[10ml:100mg\] will be used beginning with radiotherapy: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
DDP synchronous with radiotherapy
DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.
Interventions
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Tislelizumab
Tislelizumab injection\[10ml:100mg\] will be used beginning with radiotherapy: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.
DDP synchronous with radiotherapy
DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. The pathological types of cervical cancer confirmed by histopathology were squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma.
3. In FIGO stage 2018, cervical mass \> 4cm with regional lymph node metastasis, paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA.
4. Having at least one measurable lesion according to RECIST 1.1.
5. ECOG score 0-1.
6. Expected survival time ≥6 months.
7. Major organ function is normal, that is, meeting the following criteria: blood routine: HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L; Biochemical examination of ALB≥30g/L, TBIL≤1.5 ULN, ALT and AST≤2.5 ULN, plasma Cr≤1.5 ULN or creatinine clearance ≥60 ml/min.
8. Menopausal women, or women of childbearing age who meet all the following conditions: non-lactation, not pregnant, and can take adequate contraceptive measures during the study treatment.
9. Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.
Exclusion Criteria
2. Patients allergic or sensitive to any drug in the study protocol.
3. Patients innate or acquired immune deficiency (e.g. HIV infection).
4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); The subject had vitiligo. Subjects with asthma require bronchodilators for medical intervention.
5. The presence of active infections requiring systemic treatment.
6. The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.
7. Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.
8. Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.
9. Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.
10. Pregnant or lactating women.
11. Patients with liver and kidney dysfunction.
12. Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.
13. Patients who have participated in clinical trials of other drugs within 4 weeks.
14. Patients with concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or affect the patient's completion of the study.
15. The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.
18 Years
70 Years
FEMALE
No
Sponsors
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Yong Zhang,MD
OTHER
Responsible Party
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Yong Zhang,MD
First Affiliated Hospital of Guangxi Medical University
Principal Investigators
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Songqing He, PhD
Role: STUDY_CHAIR
First Affiliated Hospital of Guangxi Medical University
Locations
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First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-K046-01
Identifier Type: -
Identifier Source: org_study_id