Cervical Cancer
Conditions
Interventions
Group 1 (patients with locally advanced cervical cancer):Induction Therapy + Concurrent Chemoradiotherapy Phase + Adjuvant and Maintenance Therapy
Group 2 (Patients with stage IVB cervical cancer with oligometastasis):Induction Therapy + Concurrent Chemoradiotherapy Phase + Adjuvant and Maintenance Therapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical study; have a complete understanding of and are fully informed about this study and have signed the informed consent form; are willing and able to comply with and complete all trial procedures. 2. Histologically confirmed as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Patients with components of small cell carcinoma, neuroendocrine carcinoma, clear cell carcinoma, or sarcoma are excluded. 3. Newly diagnosed patients with Stage III-IVA disease, or Stage IVB disease with oligometastases. 4. Tumor tissue demonstrates HER2 protein expression (IHC 1+ or higher). 5. Aged 18 to 70 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 7. Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >= 80 g/L; White blood cell count (WBC) >= 3×10^9/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet count (PLT) >= 80×10^9/L; Total bilirubin (TBIL) = 50 mL/min; International normalized ratio (INR) or prothrombin time (PT) <= 1.5×ULN; 8. Have not received prior radiotherapy, chemotherapy, immunotherapy, or targeted therapy for cervical cancer. 9. The subject agrees and is able to provide archival tumor tissue samples (paraffin block or a sufficient number of unstained slides meeting the testing requirements specified for this study).
Exclusion criteria
Exclusion criteria: 1. Received other antitumor therapies (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, or monoclonal antibody therapy) within 4 weeks prior to the initiation of study treatment, or participated in clinical research of other investigational drugs that are not yet approved for marketing. 2. Known history of allergy to macromolecular protein preparations/monoclonal antibodies, or known allergy to any component of the investigational drugs. 3. Pregnant or lactating women. 4. Active autoimmune disease requiring systemic therapy (e.g., corticosteroids or immunosuppressive drugs) within the past 2 years, including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (subclinical hypothyroidism or hypothyroidism induced by prior radiotherapy/chemotherapy without clinical symptoms may be included). 5. Requirement for systemic corticosteroid therapy (at a dose equivalent to or exceeding 10 mg/day prednisone) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. 6. Presence of leptomeningeal metastases or symptomatic central nervous system metastases. 7. Received live vaccination within 4 weeks prior to the initiation of treatment. 8. Previous treatment with antitumor vaccines, or systemic antitumor therapy with immunostimulatory effects. 9. Presence of severe concurrent medical conditions, such as severe infection, uncontrolled diabetes, cardiovascular diseases (Class III or IV heart failure as defined by the New York Heart Association classification, second-degree or higher heart block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.), or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease, or history of symptomatic bronchospasm). 10. Positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb) with hepatitis B virus deoxyribonucleic acid (HBV DNA) >10^3 copies/mL, or positive hepatitis C virus antibody; positive syphilis serology. 11. History of human immunodeficiency virus (HIV) infection, or other acquired or congenital immunodeficiency diseases. 12. History of active tuberculosis infection within 1 year prior to enrollment. 13. Diagnosed with other malignancies within 5 years prior to enrollment, except for any type of carcinoma in situ that has been cured, and cured basal cell carcinoma or squamous cell carcinoma of the skin. 14. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation. 15. History of gastrointestinal perforation within 4 weeks prior to the initiation of study treatment, or underwent major surgical procedures (excluding baseline tumor biopsy) or experienced severe trauma; presence of active ulcers, intestinal perforation, intestinal obstruction, or unhealed fractures. 16. History of alcohol abuse, drug abuse, or substance abuse within the past year. 17. Clear history of neurological or psychiatric disorders, such as epilepsy or dementia, or poor compliance. 18. Other severe, acute, or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or investigational product use, or may interfere with the interpretation of study results. 19. Any other condition deemed by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year disease-free survival rate of subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median progression-free survival time of the subjects;Duration of remission in subjects;Median overall survival of the subjects;Treatment safety(NCI-CTCAE v5.0); | — |
Countries
China
Contacts
Public ContactMin Zheng; Xinping Cao
Sun Yat-sen University Cancer Center
Outcome results
None listed