Status:
RECRUITING
Iparomlimab and Tuvonralimab Combined With Paclitaxel and Cisplatin as Neoadjuvant Therapy for CC
Lead Sponsor:
Obstetrics & Gynecology Hospital of Fudan University
Conditions:
Cervical Cancers
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
Currently, the survival rate of locally advanced cervical cancer is low, posing a significant challenge in the treatment of cervical cancer. Radical chemoradiotherapy is considered the standard treatm...
Detailed Description
In recent years, anti-PD-1/PD-L1 monoclonal antibodies, as a type of immunotherapy drug, have demonstrated promising anti-tumor efficacy in the treatment of cervical cancer patients. PD-1 (Programmed ...
Eligibility Criteria
Inclusion
- Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma.
- -Arm 1 (Locally Advanced cervical cancer): Patients with locally advanced cervical cancer classified as FIGO 2018 stages IB3, IIA2, IIB, or IIICr (lesion ≥4 cm, confirmed by MRI).
- Arm2 (cervical cancer patients desiring fertility-sparing treatment): Patients with cervical cancer classified as FIGO 2018 stages IB2, IB3 (lesion ≤6 cm), IIA1, or IIA2 (lesion ≤6 cm) who have a strong desire to preserve fertility.
- 3）Planned to undergo surgical treatments of cervical cancer.
- 4\) -Arm 1 (Locally Advanced cervical cancer): Age 18-75 years.
- Arm2 (cervical cancer patients desiring fertility-sparing treatment): Age 18-45 years.
- 5\) ECOG performance status score: 0-1. 6) No prior immunotherapy received by the participant. 7) Expected survival period ≥6 months. 8) Women of childbearing potential must agree to use contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after the study ends. A negative serum or urine pregnancy test within 7 days before study enrollment is required, and the patient must not be breastfeeding.
- 9\) Adequate organ function as defined by the protocol, with test samples collected within 7 days before the start of study treatment.
- 10\) Participants voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
Exclusion
- Histological subtypes or disease stages other than those permitted in inclusion criteria 1) and 2).
- Severe hypersensitivity (≥ Grade 3) to cisplatin, paclitaxel, iparomlimab and tuvonralimab, 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) Decompensated cirrhosis (Child-Pugh class B or C); d) HBsAg-positive with HBV DNA ≥2000 IU/mL (patients with HBsAg-positive and HBV DNA \<2000 IU/mL must receive at least 2 weeks of anti-HBV therapy before the first dose); e) HCV antibody-positive with detectable HCV RNA.
- Kidney abnormalities: a) Serum creatinine \>1.5×ULN or estimated creatinine clearance \<60 mL/min using the Cockcroft-Gault formula; b) Urinalysis showing protein ≥++ and confirmed 24-hour urine protein \>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 therapy); b) History of bleeding (e.g., hemoptysis), coagulation disorders, or current use of warfarin, aspirin, low-molecular-weight heparin, or other antiplatelet agents (except for aspirin ≤100 mg/d for prophylaxis); c) Any signs or history of bleeding diathesis, regardless of severity; d) Active gastrointestinal bleeding, evidenced by hematemesis, hematochezia, or melena within the past 3 months, without resolution confirmed by endoscopy or colonoscopy; e) Any CTCAE ≥ Grade 3 bleeding or hemorrhagic event within 4 weeks before the first dose.
- 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, uncontrolled angina, coronary/peripheral artery bypass graft surgery, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack; b) Deep vein thrombosis or pulmonary embolism within 6 months before the first dose; c) Left ventricular ejection fraction (LVEF) \<50% assessed by Doppler ultrasound; d) Average QTc interval corrected by Fridericia's formula (QTcF) (based on at least 3 consecutive ECG readings): ≥470 ms for females; e) Uncontrolled hypertension (at least 2 measurements showing systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- 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 treatment, significant laboratory abnormalities, or family/social factors that may compromise patient safety.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2030
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06878222
Start Date
March 15 2025
End Date
March 31 2030
Last Update
April 1 2025
Active Locations (1)
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1
The Obstetrics & Gynecology Hospital of Fudan University
Shanghai, China