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

Yong Zhang,MD1 site in 1 country30 target enrollmentDecember 1, 2022

ConditionsUterine Cervical Neoplasms

InterventionsTislelizumab DDP synchronous with radiotherapy

DrugsTislelizumab DDP synchronous with radiotherapy

Overview

Phase: Phase 2
Intervention: Tislelizumab
Conditions: Uterine Cervical Neoplasms
Sponsor: Yong Zhang,MD
Enrollment: 30
Locations: 1
Primary Endpoint: Tumor regression ratio
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of cervical cancer patients with cervical mass > 4cm and regional lymph node metastasis, paracervical invasion and regional lymph node metastasis, stage IIIA, stage IIIB, and stage IVA. To provide a clinical reference for finding a safe and effective individualized treatment plan to improve the survival prognosis of locally advanced cervical cancer patients.

Detailed Description

This is a prospective, single-arm, single-center phase II clinical study. The objective is to evaluate the efficacy and safety of Tislelizumab combined with concurrent chemoradiotherapy in the treatment of locally advanced cervical cancer. This study was independently completed by our center. Cervical cancer patients with cervical mass \> 4cm with regional lymph node metastasis, paracervical invasion with regional lymph node metastasis, stage IIIA, stage IIIB and stage IVA in FIGO stage 2018 were selected as subjects, and 30 patients were planned to be enrolled. External irradiation 45\~50Gy/25f+ Brachytherapy 28\~30Gy/4\~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles; Tislelizumab: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.

Registry

clinicaltrials.gov

Start Date

December 1, 2022

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Yong Zhang,MD

Responsible Party

Sponsor Investigator

Principal Investigator

Yong Zhang,MD

First Affiliated Hospital of Guangxi Medical University

Eligibility Criteria

Inclusion Criteria

•Aged 18 to 70 years.
•The pathological types of cervical cancer confirmed by histopathology were squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma.
•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.
•Having at least one measurable lesion according to RECIST 1.
•ECOG score 0-
•Expected survival time ≥6 months.
•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.
•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.
•Subjects volunteered to join the study, signed the informed consent, had good compliance, and cooperated with follow-up.

Exclusion Criteria

•Patients have had or currently have other malignant tumors within 5 years.
•Patients allergic or sensitive to any drug in the study protocol.
•Patients innate or acquired immune deficiency (e.g. 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.); The subject had vitiligo. Subjects with asthma require bronchodilators for medical intervention.
•The presence of active infections requiring systemic treatment.
•The subject has previously received other PD-1 or PD-L1, or CTLA-4 antibody therapy, or other drug therapy targeting immunoregulatory receptor preparations.
•Unrelieved toxic effects above CTCAE grade 1 due to any previous treatment, excluding alopecia.
•Patients with a history of myocardial infarction or stroke, unstable angina pectoris, decompensated heart failure or deep vein thrombosis.
•Patients with long-term untreated wounds or fractures, major surgical operations or severe traumatic injuries, fractures or ulcers within 4 weeks.
•Pregnant or lactating women.

Arms & Interventions

Experimental arm

The therapeutic schedule of the experimental arm: External irradiation 45\~50Gy/25f+ Brachytherapy 28\~30Gy/4\~5f; Chemotherapy: DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles; Tislelizumab injection\[10ml:100mg\]: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.

Intervention: Tislelizumab