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Cervical CancerPhase 2NCT06149767

Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

A Phase 2 study testing Adebrelimab in people with Cervical Cancer, run by Fujian Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Prospective single-arm clinical study of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Adebrelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
No sites listed yet
Study dates
Jan 2024to Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects understand and voluntarily participate in the study, sign the informed consent form (ICF), have good compliance, and cooperate with follow-up;
  • Female, 18 years of age ≤75 years of age on the date of signing the informed consent;
  • Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma confirmed by histopathology or cytology；
  • FIGO 2018 consists of patients with stage IIB - IVA. Note: Lymph nodes with confirmed metastasis are required for diagnosis of stage ⅢC1. Lymph node metastasis diagnosis can be confirmed by biopsy or imaging diagnosis, and the following criteria must be met for imaging diagnosis of lymph node metastasis: MRI or CT showing positive lymph nodes (minimum transverse diameter ≥15 mm)
  • Have not previously received any radical surgery, radiotherapy or systemic treatment (including investigational drugs) for cervical cancer, and have not received immunotherapy;
  • An American Eastern Oncology Collaboration (ECOG) score of 0 or 1 within 7 days prior to the first study intervention;
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  • There is at least one measurable lesion that meets the requirements of RECIST v1.1 standard (tumor lesion with CT scan diameter ≥10mm, lymph node lesion with CT scan diameter ≥15mm, and scan layer thickness 5mm);
  • Expected survival ≥6 months;
  • The major organs function normally and meet the following criteria:
  • Blood routine examination must meet:
  • Hemoglobin (Hb)≥90g/L
  • White blood cell count (WBC)≥3×109/L
  • Neutrophil count absolute value (ANC)≥1.5×109/L
  • Platelet count (PLT)≥100×109/L； (2) Biochemical examination shall meet the following standards:
  • Serum total bilirubin (TBIL) ≤1.5 × ULN (total bilirubin (BIL)≤3.0 mg/dL in patients diagnosed with Gilbert syndrome) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3ULN c. Albumin (ALB) ≥3 g/dL d. Serum Cr≤1.5ULN, endogenous creatinine clearance ≥60ml/min (Cockcroft-Gault formula)； (3) The coagulation function test shall meet the following criteria:
  • International Standardized Ratio (INR) ≤1.5
  • Activated partial thromboplastin time (APTT) ≤1.5 ×ULN； 10. In potentially fertile women, serum or urine HCG negative for 72 hours prior to enlistment (postmenopausal women must be considered infertile for at least 12 months and a pregnancy test is not required for women who have been confirmed to have undergone tubal ligation), Female subjects of reproductive age and male subjects with a partner of a woman of reproductive age must consent to contraception for 24 weeks from the date of signing the informed consent to the last administration of the study drug.

Who cannot join

  • Subjects have histological subtypes other than those permitted by inclusion criteria 3;
  • Evidence of metastatic lesions according to RECIST 1.1 (including proximal L1 level or above or inguinal regional lymph nodes);
  • Have had a hysterectomy (defined as removal of the entire uterus) or had a hysterectomy as part of their initial treatment for cervical cancer;
  • Bilateral hydronephrosis, which the investigators judged could not be relieved by nephrostomy or ureteral stenting;
  • Patients with uncontrolled vaginal bleeding;
  • Previous allergy to any investigational drug ingredient;
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  • Participate in clinical studies of other investigational drugs within 3 months prior to screening;
  • Other malignancies developed within 5 years prior to admission, excluding adequately treatable basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
  • Have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitaritis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); Except for patients with vitiligo or childhood asthma/allergies that have healed and do not require any intervention as adults; Autoimmune mediated hypothyroidism treated with a steady dose of thyroid replacement hormone; Type 1 diabetes using steady doses of insulin;
  • A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation and allogeneic bone marrow transplantation;
  • Accompanied by serious heart, lung, liver, kidney disease; Having neurological or mental illness; Jaundice or digestive tract obstruction with severe infection;
  • Patients with hypertension who are not well controlled by antihypertensive drugs (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); Or grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women); According to NYHA criteria, patients with grade Ⅲ to Ⅳ cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
  • Urine routine suggests urinary protein ≥(++), or 24h urinary protein ≥1g or severe hepatic and renal insufficiency;
  • Patients with Crohn's disease and ulcerative colitis;
  • Subjects who have received systemic treatment with corticosteroids (>10 mg/ day of prednisone or other equivalent hormones) or other immunosuppressants within 2 weeks prior to initial dosing. In the absence of active autoimmune disease, inhaled or topical corticosteroids are permitted, as well as adrenal hormone replacement therapy at doses ≤10 mg/ day of prednisone efficacy;
  • Pregnant or lactating women, fertile subjects unwilling or unable to take effective contraceptive measures;
  • Those deemed unsuitable for inclusion by the researchers.

About this study

Official title: Clinical Study of Adbelizumab Combined With Concurrent Chemoradiotherapy in Locally Advanced Cervical Cancer

Prospective single-arm clinical study of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer

Read the detailed description

To evaluate the efficacy and safety of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer

Conditions
Cervical Cancer
Being tested
Adebrelimab
Keywords
Cervical cancer, adebrelimab
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.

  • AdebrelimabDrug

    Also called Paclitaxel for Injection,cisplatin,radiotherapy

    The medication regimen for all enrolled patients is as follows, and the dose can be adjusted during treatment due to adverse reactions and other circumstances:

    Adebrelimab : 20 mg/kg, D1, intravenously, 30-60 min, Q3w. Paclitaxel for Injection: 150 mg/m2, D1 Cisplatin: 50 mg/m2, IV, D1, Q3w. Radiotherapy: pelvic dose: 6MV-X, 180cGy/ times 27 times; Brachydose: 192Ir, 700cGy/ time 4 times.

    First of all, after 2 cycles of concurrent chemoradiotherapy, the sequential chemotherapy combined with adbalizumab for 2-4 cycles, and the subsequent investigators selected Adbalizumab or other drugs to maintain the treatment according to the patient's situation or the patient's own will until the disease progressed or intolerable toxicity occurred or the subjects voluntarily withdrew from the study.adebrelimab until disease progression or intolerable toxicity or the subject voluntarily withdrew from the study。

Study groups in NCT06149767
Study groupRoleWhat they receive
Adebrelimab Combined With Paclitaxel for Injection,cisplatin and radiotherapyExperimentalAdebrelimab : 20 mg/kg, D1, intravenously, 30-60 min, Q3w. Paclitaxel for Injection: 150 mg/m2, D1 Cisplatin: 50 mg/m2, IV, D1, Q3w. Radiotherapy: pelvic dose: 6MV-X, 180cGy/ times 27 times; Brachydose: 192Ir, 700cGy/ time 4 times.
Receives: Drug: Adebrelimab

What is being measured

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

  1. To evaluate the 2-year PFS rate of adbelizumab combined with concurrent chemoradiotherapy in locally advanced cervical cancer.

    To evaluate the 2-year PFS rate of adebrelimab combined with concurrent,Progression-free survival (PFS) as assessed by the investigators according to RECIST 1.1 criteria chemoradiotherapy in locally advanced cervical cancer

    Measured: up to 24 months

  2. To evaluate the 2-year safety of adbelizumab combined with concurrent chemoradiotherapy in locally advanced cervical cancer.

    evaluate the safety of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer,The security as assessed by the investigators according to CTCAE 5.0 criteria,All adverse events will also be rated based on the CTCAE version 5.0, and AEs greater than or equal to grade 3 will be statistically summarised.

    Measured: up to 24 months

Secondary outcomes (3)

  1. To evaluate the objective remission rate of adebrelimab combined with concurrent chemoradiotherapy in local advanced cervical cancer

    To evaluate the objective remission rate of adebrelimab combined with concurrent chemoradiotherapy in local advanced cervical cancer

    Measured: up to 12 months

  2. To evaluate the disease control rate of adebrelimab combined with concurrent chemoradiotherapy in local advanced cervical cancer

    To evaluate the disease control rate of adebrelimab combined with concurrent chemoradiotherapy in local advanced cervical cancer

    Measured: up to 24 months

  3. To evaluate the overall survival of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer

    To evaluate the overall survival of adebrelimab combined with concurrent chemoradiotherapy in locally advanced cervical cancer

    Measured: up to 24 months

Timeline

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

  1. First posted29 Nov 2023
  2. Study startJan 2024 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMar 2028 (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
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06149767
Sponsor's protocol ID
23-OBU-FJ-CA-001
Status last verified
Nov 2023
First submitted
14 Sep 2023
Last updated
29 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab in people with Cervical Cancer, run by Fujian Cancer Hospital.

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 17 inclusion and 17 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: opening soon, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the 2-year PFS rate of adbelizumab combined with concurrent chemoradiotherapy in locally advanced cervical cancer. (time frame: up to 24 months). The study lists 2 primary outcomes in all. 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 NCT06149767.

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 29 Nov 2023.

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