Locally advanced cervical cancer
Conditions
Interventions
Neoadjuvant therapy + surgical treatment group:Bemosubemab plus chemotherapy with/without anlotinib neoadjuvant therapy
Sponsors
Obstetris & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Willing to sign the informed consent form and able to comply with the protocol requirements; 2. Patients aged 18–70 with primary cervical cancer; 3. Clinically diagnosed with cervical cancer stage IB3, IIA2, or IIIC1 (FIGO staging, 2018); 4. According to RECIST 1.1 criteria, measurable cervical lesions by imaging >=4 cm; 5. Histological types include cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 6. No prior radiotherapy, chemotherapy, or targeted therapy; 7. ECOG score of 0–1, with an expected survival of over 3 months; 8. Major organ function meets the requirements for surgery, chemotherapy, and radiotherapy: (1) Complete blood count (within 7 days before screening, without transfusion or hematopoietic growth factors): 1) Hemoglobin (HB) >= 80 g/L; 2) Absolute neutrophil count (ANC) >= 1.8 × 10^9/L; 3) Platelets (PLT) >= 80 × 10^9/L; (2) Biochemical tests (within 7 days before screening, without transfusion or albumin): 1) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 ml/min; (3) Coagulation function tests: 1) Activated partial thromboplastin time (APTT), international normalized ratio (INR), prothrombin time (PT) = 50%.
Exclusion criteria
Exclusion criteria: 1. Concurrent participation in another clinical trial, or completion of another clinical trial within 4 weeks prior to enrollment. 2. Failure to recover from adverse events (except for alopecia) related to prior therapies. 3. Major surgery performed within 6 weeks prior to enrollment. 4. Clinically significant hemoptysis (> 50 mL per day) within 3 months prior to enrollment or significant clinical bleeding symptoms or a clear tendency for hemorrhage, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood test = (++), or vasculitis. 5. Arterial or venous thrombotic events within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis (except for catheter-related thrombosis resolved after prior chemotherapy, as judged by the investigator), and pulmonary embolism. 6. Within 6 months prior to enrollment, any of the following: myocardial infarction, severe/unstable angina, cardiac function of Class II or higher per NYHA classification, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure. 7. Diagnosis of any other malignancy within 3 years prior to study entry (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or other cancers considered cured by the investigator). 8. Comorbidities: any active autoimmune disease or history of autoimmune disease congenital or acquired immunodeficiency (e.g., HIV infection) hypertension poorly controlled with medication (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) coagulation disorders (INR >2.0, PT >16 s), bleeding tendency, or ongoing thrombolytic/anticoagulant therapy interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia) hepatic dysfunction (AST/ALT >2.5 × ULN) renal insufficiency (serum creatinine >2 × ULN). 9. Prior or planned allogeneic bone marrow or solid organ transplant history of major organ transplantation or immunological diseases. 10. History of severe allergy to macromolecular or micromolecular drugs, or known allergy to Anlotinib, Bemotuzumab injection, or any component of the Paclitaxel or Cisplatin/Carboplatin formulations. 11. Current use of immunosuppressive agents or systemic corticosteroid therapy for immunosuppressive purposes (at doses >10 mg prednisone daily or equivalent) within 2 weeks prior to enrollment. 12. Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study period. 13. Any other serious physical or mental illness, or abnormal laboratory finding that, in the investigator's judgment, may increase the risk associated with study participation, interfere with the interpretation of study results, or make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR);Optimal Pathological Response (OPR, residual tumor <3mm); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);3-year DFS rate;Treatment-related adverse events (TRAEs);Quality of Life (CC-PRO137 Scale Assessment); | — |
Countries
China
Contacts
Public ContactJingxin Ding
Obstetris & Gynecology Hospital of Fudan University
Outcome results
None listed