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Platinum-sensitive Relapsed Ovarian CancerPhase 2NCT06446206

Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer

A Phase 2 study testing Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib in people with Platinum-sensitive Relapsed Ovarian Cancer, run by The First Hospital of Jilin University.

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

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
No sites listed yet
Study dates
Jun 2024to Jun 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

  • Patients volunteered to participate in this study after full informed consent and signed a written informed consent form;
  • Aged 18-75 years old;
  • Pathologically confirmed ovarian epithelial cancer, epithelial fallopian tube cancer, or primary peritoneal cancer;
  • International Federation of Gynecology and Obstetrics (FIGO) 2018 edition staging III-IV;
  • Having received no more than 2 prior lines of platinum-containing chemotherapy and ≥ 6 months between the time of last chemotherapy and tumor recurrence;
  • No more than 1 prior PARP inhibitor;
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  • Negative for germline breast cancer susceptibility gene(BRCA) mutations;
  • At least 1 measurable lesion according to RECIST 1.1 evaluation criteria;
  • Patients with expected survival of ≥12 weeks;
  • Have an Eastern Cooperative Oncology Group(ECOG) Performance Status(PS) score of 0-1;
  • The patient has good organ function: without having received transfusions of blood products, granulocyte colony-stimulating factor, interleukin 11, thrombopoietin, or thrombopoietin receptor agonists within 14 days prior to the first receipt of therapeutic agents in this regimen：
  • Neutrophil count ≥1.5 x 10^9/L.
  • platelet count ≥ 80 × 10^9/ L.
  • hemoglobin ≥75 g/L.
  • albumin ≥30 g/L.
  • Albumin ≥30 g/L
  • Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • Alanine amino transferase(ALT), Aspartate amino transferase(AST) ≤ 3 times ULN (without liver metastases) or ≤ 5 times ULN (if liver metastases occur)
  • Serum creatinine ≤1.5 times upper limit of normal (ULN)
  • Requirements for coagulation: international normalized ratio (INR) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN.
  • Corrected serum electrolytes within normal range;
  • Women of childbearing potential must have had a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception for the duration of the trial and for 8 weeks after the last administration of the test drug.

Who cannot join

  • Known hypersensitivity or severe allergic reactions to the study drug or any of its excipients;
  • Concurrent other incurable malignancies;
  • The presence of uncontrolled or symptomatic active central nervous system (CNS) metastases;
  • Pregnancy or confirmed by blood or urine Human Chorionic Gonadotropin(HCG) test or lactation, or subjects of childbearing potential who are unwilling or unable to use effective contraception (for both male and female subjects) until at least 6 months after the last trial treatment;
  • Difficult-to-control diabetes mellitus (defined as high fluctuations in blood glucose that interfere with the patient's life as well as frequent hypotension despite standard insulin therapy and frequent blood glucose monitoring);
  • Myocardial infarction, severe/unstable angina pectoris, New York Heart Association(NYHA) class 2 or greater cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias and symptomatic congestive heart failure, uncontrolled hypertension of moderate or greater severity (Systolic Blood Pressure >160 mm Hg or Diastolic Blood Pressure >100 mm Hg) within 4 weeks prior to the first study dose, known coronary artery disease, congestive heart failure that does not meet the above criteria congestive heart failure or left ventricular ejection fraction <50% that meets the above criteria must be treated with an optimally stabilized medical regimen as determined by the treating physician and, if appropriate, in consultation with a cardiologist;
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  • Patients with a history of neurologic autoimmune disease, or moderate to severe autoimmune disease, or high doses of immunosuppressive agents for symptom control
  • History of known allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Receipt of any of the following medications or treatments prior to the first study drug treatment
  • major surgery within 6 weeks (tissue biopsies and Peripherally Inserted Central Catheter or infusion port implantation via peripheral venous puncture for diagnostic purposes are permitted)
  • Requires ongoing high-dose systemic corticosteroids (>10 mg/day prednisone or equivalent dose of other medications) or other systemic immunosuppressants (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, tacrolimus, cyclosporine, meclofenamic acid esters, anti-thymocyte globulin, and anti-tumor necrosis factor medications), and continues to be required after enrollment; [Note]: Topical skin, ocular, intra-articular, intranasal, and inhaled corticosteroids are permitted .
  • Serious infections within 90 days, such as severe pneumonia requiring hospitalization, bacteremia, and co-infections; active tuberculosis; [Note 1] Hepatitis B Surface Antigen Positive (HBsAg+) and/or Hepatitis B Core Antibody Positive (HBcAb+) patients will be required to undergo a Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) test, if the HBV DNA copy number <1000 cps/mL, or less than the lower limit of detectable value of the research center, can participate in this study and regulate the use of anti-hepatitis B virus medication; [Note 2] patients with hepatitis C antibody positive (HCV Ab+) need to undergo HCV RNA testing, and HCV RNA negative (defined as less than the lower limit of detectable value of the research center) can participate in this study;
  • Psychiatric disorders that interfere with informed consent and/or protocol adherence;
  • Other conditions that, in the judgment of the investigator, make participation in this study inappropriate.

About this study

Official title: Adebrelimab Plus Chemotherapy and Bevacizumab Induction Therapy Followed by Maintenance Therapy With Adebrelimab Plus Fluzoparib and Bevacizumab in Platinum-Sensitive Relapsed Ovarian Cancer (CHANGCHUN): A Single-Arm, Exploratory Study

The investigators explore the efficacy and safety of adebrelimab (PD-L1 inhibitor) plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib (PARP inhibitor)and bevacizumab in platinum-sensitive relapsed ovarian cancer.

Being tested
Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib

What participants receive

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

  • Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparibDrug

    Adebrelimab plus paclitaxel, carboplatin and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib and bevacizumab.

Study groups in NCT06446206
Study groupRoleWhat they receive
Experimental armExperimentalNot described
Receives: Drug: Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib

What is being measured

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

  1. 12-month progression-free survival rate

    Measured: Twelve months after patients received their first antitumor drug therapy.

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Measured: The radiological evaluations will be performed once at the end of every 2 cycles within 6 cycles and once every 4 cycles after Cycle 6(each cycle is 21 days).

  2. Progression-free survival of CR/PR

    Progress Free Survival (PFS) in patients with complete response (CR)/partial response (PR) after induction chemotherapy.

    Measured: The time from the first dose of investigational product to the first progression of disease (PD) in radiological evaluation or death for any reason (whichever comes first), assessed up to 2 years .

  3. Progression-free survival of SD

    Progress Free Survival (PFS) in patients with stable disease (SD) after induction chemotherapy.

    Measured: The time from the first dose of investigational product to the first progression of disease (PD) in radiological evaluation or death for any reason (whichever comes first), assessed up to 2 years .

  4. Overall Survival（OS）

    Measured: The time from the first dose of investigational product to the death for any reason, assessed up to 2 years.

Timeline

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

  1. First posted6 Jun 2024
  2. Study startJun 2024 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 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
22 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06446206
Sponsor's protocol ID
2024-HS-022
Status last verified
Jun 2024
First submitted
22 May 2024
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab, paclitaxel, carboplatin, bevacizumab, fluzoparib in people with Platinum-sensitive Relapsed Ovarian Cancer, run by The First Hospital of Jilin University.

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 22 inclusion and 14 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 6 Jun 2024. 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?

12-month progression-free survival rate (time frame: Twelve months after patients received their first antitumor drug therapy.). 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 NCT06446206.

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 6 Jun 2024.

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