Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

NCT05588219 | Unknown Phase 2

• 1 other identifier: 2022-K046-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical cancer; Tislelizumab; Concurrent chemoradiotherapy

Outcome Measures

Primary Outcomes (1)

• Tumor regression ratio

  The tumor regression ratio after external irradiation, MRI/CT will be used for evaluating the carcinoma status.

  2 weeks

Secondary Outcomes (3)

• Overall Response Rate

  3 months, 6 moths

• Overall Survival

  1 years, 3 years

• Progression Free Survival

  1 years, 3 years

Study Arms (1)

Experimental arm

EXPERIMENTAL

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.

Drug: Tislelizumab; Drug: DDP synchronous with radiotherapy

Interventions

Tislelizumab DRUG

Tislelizumab injection\[10ml:100mg\] will be used beginning with radiotherapy: 200mg/3W for 1 year or disease progression or intolerable toxicity, whichever occurs first.

Also known as: Immune checkpoint inhibitors

Experimental arm

DDP synchronous with radiotherapy DRUG

DDP 40mg/m2/W, synchronous with radiotherapy, complete at least 4 cycles.

Also known as: Cisplatin

Experimental arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.1.
• ECOG score 0-1.
• 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.

You may not qualify if:

• 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.
• Patients with liver and kidney dysfunction.
• Patients with a history of abuse of psychotropic drugs and unable to abstain or patients with mental disorders.
• Patients who have participated in clinical trials of other drugs within 4 weeks.
• 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.
• The investigator judged that participation in this study was not conducive to the maximum benefit of the subjects.

Sponsors & Collaborators

• Yong Zhang,MD: lead

Study Sites (1)

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

tislelizumab; Immune Checkpoint Inhibitors; Radiotherapy; Cisplatin

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Songqing He, PhD

  First Affiliated Hospital of Guangxi Medical University

  STUDY CHAIR

Central Study Contacts

Yong Zhang, PhD

CONTACT

13607884001; zhangyonggx@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: First Affiliated Hospital of Guangxi Medical University

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 20, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)