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New treatment option for Cervical Cancers
Official title Ivonescimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy Followed by Type A Hysterectomy in Stage IB2 and IIA1 Cervical Cancer
ClinicalTrials.gov ID: NCT07130240
What this study is testing
What is Neoadjuvant Chemotherapy Combined with Immunotherapy?
Neoadjuvant Chemotherapy Combined with Immunotherapy is an investigational medicine, being studied as a potential treatment for cervical cancers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cervical cancer ranks fourth globally in both incidence and mortality rates, making early diagnosis and treatment of great significance. For early-stage cervical cancer, surgery remains the primary treatment approach.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- (1)Patients with FIGO 2018 stages IB2, IIA1 (2\< lesion ≤4 cm, confirmed by MRI); (2) Histologically confirmed cervical squamous cell carcinoma...
- (8) Adequate organ function as defined by the protocol, with test samples collected within 7 days before the start of study treatment.
- (9) Participants voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
You likely can't join if
- Histological subtypes or disease stages other than those permitted in inclusion criteria (1) and (2).
- Severe hypersensitivity (≥ Grade 3) to cisplatin, paclitaxel, Ivonescimab , and/or any of their excipients.
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Administration of inactivated vaccines within 30 days before the first study treatment or planned vaccination during the study period.
- Treatment with systemic immunostimulants, colony-stimulating factors, interferons, interleukins, or combination vaccines within 6 weeks or 5...
- Diagnosis of immunodeficiency or chronic systemic steroid therapy (exceeding 10 mg prednisone equivalent per day) or any other form of...
See the full eligibility criteria
- (1)Patients with FIGO 2018 stages IB2, IIA1 (2\< lesion ≤4 cm, confirmed by MRI); (2) Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma; (3)18-75...
- (8) Adequate organ function as defined by the protocol, with test samples collected within 7 days before the start of study treatment.
- (9) Participants voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
- Histological subtypes or disease stages other than those permitted in inclusion criteria (1) and (2).
- Severe hypersensitivity (≥ Grade 3) to cisplatin, paclitaxel, Ivonescimab , and/or any of their excipients.
- Participation in another clinical trial within 4 weeks prior to enrollment.
- Administration of inactivated vaccines within 30 days before the first study treatment or planned vaccination during the study period.
- Treatment with systemic immunostimulants, colony-stimulating factors, interferons, interleukins, or combination vaccines within 6 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Diagnosis of immunodeficiency or chronic systemic steroid therapy (exceeding 10 mg prednisone equivalent per day) or any other form of immunosuppressive therapy within 7 days before the first dose.
- Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within the past 2 years.
- History of (non-infectious) pneumonitis requiring steroid treatment or current (non-infectious) pneumonitis.
- Active infection requiring systemic treatment.
- Known history of HIV infection.
- Known history of hepatitis B (defined as HBsAg reactivity) or active hepatitis C virus infection (defined as detectable HCV RNA [qualitative]).
- Known history of active tuberculosis (TB; Mycobacterium tuberculosis).
- Prior allogeneic tissue/solid organ transplantation.
- Central nervous system metastases, such as brain metastases.
- Uncontrolled pleural or peritoneal effusion.
- Impaired mobility due to pathological fractures caused by bone metastases.
- Insufficient bone marrow function (without transfusion within 14 days): a) Absolute neutrophil count (ANC) \<1.5×10⁹/L;b) Platelets \<100×10⁹/L; c) Hemoglobin \<9 g/dL.
- Liver abnormalities: a) ALT, AST, or ALP \>2.5× upper limit of normal (ULN) without liver metastasis or \>5×ULN with liver metastasis; b) Total bilirubin \>1.5×ULN (\>3×ULN in patients with Gilbert's syndrome); c)...
- Kidney abnormalities: a) Serum creatinine \>1.5×ULN or estimated creatinine clearance \ 1.0 g; c) Renal failure requiring hemodialysis or peritoneal dialysis; d) History of nephrotic syndrome.
- Bleeding risk: a) Coagulation abnormalities: Activated partial hromboplastin time (APTT) or thrombin time (TT) \>1.5×ULN, or international normalized ratio (INR) \>1.5 (\>2.5 for patients requiring anticoagulation...
- Cardiovascular and cerebrovascular abnormalities: a) Any of the following within 12 months before the first dose: ≥ Grade 2 myocardial ischemia, yocardial infarction, arrhythmias, ≥ Grade 3 cardiac insufficiency...
- Other factors judged by the investigator as potentially affecting study results or leading to premature termination, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concurrent...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.