Overview
To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.
Description
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
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:
- Diagnosed with any other cancer within the past 5 years;
- Known allergy to any component of the drug;
- Congenital or acquired immune deficiency (such as HIV infection);
- 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;
- Active infection requiring systemic treatment;
- Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors;
- 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;
- With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis;
- Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;
- Pregnant or lactating women;
- With metastatic diseases;
- Liver/renal insufficiency;
- Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders;
- Those who have participated in clinical trials with other drugs within 4 weeks;
- Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator;
- Patients could not gain the maximum benefit from this study judged by the investigator.
