tislelizumab combined with concurrent chemoradiotherapy as first-line treatment for stage iiic2 cervical cancer

Conditions: Cervical Cancer

Summary: to evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage iiic2 cervical cancer.

this is a multicenter, prospective, and randomized phase ii clinical trial. patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks. compare the efficacy and toxicity of the two regimens in patients with stage iiic2 cervical cancer.

Eligibility criteria:
inclusion criteria: (1)18-70 years old; (2)histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)patients with 2018 figo stage iiic2 cervical cancer; (4)at least one measurable lesion according to the response evaluation criteria in solid tumours (recist) 1.1; (5)eastern cooperative oncology group score 0-1; (6)no metastatic diseases; (7)must have an average life expectancy of 6 months; (8)participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g/l,neutrophils ≥1.5×109/l, platelets ≥80×109/l, alb≥30g/l, total bilirubin≤1.5 x institutional upper limit of normal, ast(sgot)/alt(sgpt) ≤2.5 × institutional upper limit of normal, creatinine clearance≥60 ml/min; (9)patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)patients volunteered to participate in the study and sign the informed consent. exclusion criteria: 1. diagnosed with any other cancer within the past 5 years; 2. known allergy to any component of the drug; 3. congenital or acquired immune deficiency (such as 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.); medical history of vitiligo; asthma which requires bronchodilators for medical intervention; 5. active infection requiring systemic treatment; 6. previously treatment with pd-1 and/or pd-l1, or ctla-4 antibody, or other medications targeting immunomodulatory receptors; 7. patients with grade\>2 unrelieved toxic reactions (based on national cancer institute common terminology criteria for adverse events \[nci ctcae\] version 5.0) caused by any previous treatment; 8. with a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis; 9. long-term uncured wounds or fractures; major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 10. pregnant or lactating women; 11. with metastatic diseases; 12. liver/renal insufficiency; 13. those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 14. those who have participated in clinical trials with other drugs within 4 weeks; 15. patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator; 16. patients could not gain the maximum benefit from this study judged by the investigator.

Keywords: cervical carcinoma pd-1 chemoradiotherapy