Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

Launched by YONG ZHANG,MD · Oct 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for women with locally advanced cervical cancer, specifically those with larger tumors and cancer spread to nearby lymph nodes. The treatment being tested combines a medication called Tislelizumab with standard chemotherapy and radiation therapy. The goal is to see if this combination can improve the effectiveness and safety of treatment, ultimately helping patients live longer.

To be eligible for the trial, women aged 18 to 70 who have specific types of cervical cancer and meet certain health criteria can participate. These criteria include having a tumor larger than 4 cm and evidence of cancer spread. Participants will receive the study treatment and will be closely monitored for their health and response to the treatment. It's important to know that individuals with certain health issues or those who are pregnant or breastfeeding cannot join the study. Overall, this trial aims to find a more personalized and effective treatment plan for women facing advanced cervical cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 to 70 years.
• • 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:
• • 1. Patients have had or currently have other malignant tumors within 5 years.
• • 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.