locally advanced cervical cancer (Stage IIB–IVA)
Conditions
Interventions
Patients with locally advanced cervical cancer.:None
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >= 18 years at the time of signing the informed consent form. 2. Pathologically confirmed diagnosis of cervical cancer, including squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma. 3. Staged as stage IIB, IIIA, IIIB, IIIC1r and IVA according to the 2018 FIGO staging system. 4. Presence of measurable lesions assessed per RECIST 1.1 criteria. 5. Patients confirmed to have indications for carbon ion radiotherapy after departmental MDT discussion. 6. Patients voluntarily receive carbon ion radiotherapy at Zhejiang Cancer Hospital and bear the relevant expenses. 7. Complete clinical and imaging data are available. 8. Willing to participate in the study and accept questionnaire surveys. 9. Willing to participate in the study and provide specimens, including cervical tissue, various body fluid samples and tissue samples. 10. Willing to undergo regular standardized outpatient follow-up in our hospital. 11. Eastern Cooperative Oncology Group performance status (PS) score of 0–2. 12. No prior history of surgery, radiotherapy or chemotherapy for cervical cancer. 13. Normal function of major vital organs (bone marrow, liver, kidney, etc.) within one week before treatment, meeting the following laboratory criteria: (1) Absolute neutrophil count (ANC) >= 1500/µL; (2) Platelet count >= 100,000/µL; (3) Hemoglobin >= 9.0 g/dL or >= 5.6 mmol/L; (4) Creatinine clearance >= 50 mL/min; (5) Total bilirubin 1.5 × ULN, direct bilirubin = 6 months.
Exclusion criteria
Exclusion criteria: 1. Presence of severe uncontrolled complications, such as intractable cardiovascular disease, uncontrolled hypertension and diabetes, refractory infection, acute peptic ulcer, uncontrolled psychiatric disorders, etc. 2. Concurrent active second primary malignancy. 3. Tumor invasion of the rectum (Stage ?A) or peritoneal metastasis (M1). 4. Prior treatment with immunotherapy agents, including anti-PD-1, anti-PD-L1, anti-CTLA-4 and other immune checkpoint inhibitors. 5. Prior radical surgery, radiotherapy or systemic therapy (including investigational drugs) for cervical cancer. Note: Local cervical conization is permitted. 6. Use of any investigational drugs within 4 weeks prior to initiation of immunotherapy. 7. Diagnosis of immunodeficiency; or receipt of chronic systemic corticosteroid therapy (prednisone equivalent dose >10 mg daily) or other immunosuppressive therapy within 7 days before immunotherapy initiation. 8. History of grade =3 severe hypersensitivity reaction to immunotherapy agents. 9. Active autoimmune disease requiring systemic treatment within the past 2 years (excluding replacement therapy such as thyroxine, insulin, and physiological glucocorticoids). 10. Previous history of hormone-treated (non-infectious) pneumonitis/interstitial lung disease, or current active pneumonitis/interstitial lung disease. 11. Active infection requiring systemic treatment. 12. History of active hepatitis B (HBsAg positive) or active hepatitis C (detectable HCV RNA). 13. Presence of any disease, treatment, laboratory abnormality, or other condition that, in the investigator’s judgment, may interfere with study outcomes, affect full study participation, or be detrimental to the subject. 14, Known psychiatric illness or substance abuse that may compromise treatment compliance; pregnant or lactating females, or those planning pregnancy/childbirth during the study period (from screening to 120 days after the last study treatment). 15. History of allogeneic tissue/solid organ transplantation. 16. History of HIV infection. 17. Presence of metal implants in the radiation field path that may compromise the accuracy of radiotherapy dose calculation. 18. Voluntary withdrawal from the study at the patient’s request.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival, OS ;Side effects related to radiation, chemotherapy, and immunotherapy, Radiation Therapy Oncology Group?/Common Terminology Criteria for Adverse Events, RTOG/CTCAE; | — |
Countries
China
Contacts
Public ContactLouHanmei
Zhejiang Cancer Hospital
Outcome results
None listed