Combining Tislelizumab with Chemoradiotherapy for Advanced Cervical Cancer

Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Single-center, Phase II Clinical Study

This study is testing if adding a new drug called Tislelizumab to standard treatment can help people with advanced cervical cancer live longer and feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: First Affiliated Hospital of Guangxi Medical University (Academic / other)
• Drugs / interventions: Tislelizumab, Chemotherapy
• Locations: 1 site (Nanning, Guangxi)
• Trial ID: NCT05588219 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of Tislelizumab when used alongside concurrent chemoradiotherapy in patients with locally advanced cervical cancer. The study focuses on patients with cervical masses larger than 4 cm and regional lymph node metastasis, specifically those classified as stage IIIA, IIIB, and IVA. It is a prospective, single-arm, single-center phase II study aiming to enroll 30 patients, who will receive a combination of external irradiation, brachytherapy, chemotherapy, and Tislelizumab over a year or until disease progression. The goal is to establish a safe and effective individualized treatment plan to improve survival outcomes for these patients.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 70 with specific types of cervical cancer in advanced stages and measurable lesions.

Not a fit: Patients with early-stage cervical cancer or those with contraindications to the treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve survival rates for patients with advanced cervical cancer.

How similar studies have performed: While similar approaches have been explored, this specific combination of Tislelizumab with concurrent chemoradiotherapy is relatively novel.

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.

Where this trial is running

Nanning, Guangxi

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

Study contacts

• Study coordinator: Yong Zhang, PhD

Conditions Uterine Cervical Neoplasms; Cervical cancer; Tislelizumab; Concurrent chemoradiotherapy