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Uterine Cervical NeoplasmsPhase 2NCT05588219

Tislelizumab Combined With Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer

A Phase 2 study testing Tislelizumab and DDP synchronous with radiotherapy in people with Uterine Cervical Neoplasms, run by Yong Zhang,MD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Uterine Cervical Neoplasms
What is being tested?
Tislelizumab and DDP synchronous with radiotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Dec 2022to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Yong Zhang, PhD contact

13607884001

zhangyonggx@163.com

China1 site, 1 recruiting

  • First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Yong Zhang, PhD, 13607884001, zhangyonggx@163.com

    Shanshan Ma, PhD, 13557994302, mashanshan@gxmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Tislelizumab, DDP synchronous with radiotherapy
Keywords
Cervical cancer, Tislelizumab, Concurrent chemoradiotherapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabDrug

    Also called Immune checkpoint inhibitors

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

  • DDP synchronous with radiotherapyDrug

    Also called Cisplatin

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

Study groups in NCT05588219
Study groupRoleWhat they receive
Experimental armExperimentalThe 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.
Receives: Drug: Tislelizumab; Drug: DDP synchronous with radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tumor regression ratio

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

    Measured: 2 weeks

Secondary outcomes (3)

  1. Overall Response Rate

    The overall response rate or tumor after radiotherapy and chemotherapy, and MRI/CT will be used for evaluating the carcinoma status.

    Measured: 3 months, 6 moths

  2. Overall Survival

    OS was calculated from the date of entry into the study to the date of death or the last follow-up visit.

    Measured: 1 years, 3 years

  3. Progression Free Survival

    PFS was calculated from the date of entry into the study to the date of first physical or radio-graphic evidence of disease progression, death or the last follow-up visit.

    Measured: 1 years, 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start1 Dec 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588219
Sponsor's protocol ID
2022-K046-01
Status last verified
Nov 2023
First submitted
18 Oct 2022
Last updated
24 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab and DDP synchronous with radiotherapy in people with Uterine Cervical Neoplasms, run by Yong Zhang,MD at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong Zhang, PhD (13607884001, zhangyonggx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor regression ratio (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05588219.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.

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