Combining tislelizumab with chemoradiotherapy for advanced cervical cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of tislelizumab, an immune checkpoint inhibitor, when combined with standard chemoradiotherapy in patients with stage IIIC2 cervical cancer. It is a multicenter, prospective, and randomized phase II trial where participants are assigned to either receive the experimental treatment or standard care. The experimental group will receive concurrent chemoradiotherapy with cisplatin and tislelizumab, while the control group will receive only chemoradiotherapy with cisplatin. The study aims to compare the effectiveness and toxicity of these two treatment regimens.

Why it matters

Who can join: the full rules

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.

Where it's running

• First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting

Study contacts

• Principal investigator: fang wu, M.D. — First Affiliated Hospital of Guangxi Medical University
• Study coordinator: shanshan ma, M.D.
• Email: 56716690@qq.com
• Phone: 07715356509

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.