Cervical cancer
Conditions
Interventions
Investigation group:QL1706 combined withdual-drug chemotherapy (albumin paclitaxel + cisplatin/carboplatin) +/- bevacizumab and radical radiotherapy
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 - 75 years old; 2. Initial diagnosis of stage IVB without treatment, with synchronous oligometastasis (= 10mm, the short diameter of the lymph node lesion on MR/CT scan >= 15mm); 5. Receive pelvic radical radiotherapy and individualized local treatment for oligometastatic lesions; 6. General physical condition (PS) score: 0 - 1 point; 7. Expected survival period >= 6 months; 8. Bone marrow function: White blood cell count > 4×10^9/L, hemoglobin > 70g/L (or moderate to severe anemia can be corrected by blood transfusion) and platelet count > 100×10^9/L; 9. Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels = 40mL/min (using the standard Cockcroft-Gault formula); 11. The subject has signed the informed consent form and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: 1. Participants deemed ineligible by investigators for inclusion 2. History of hypersensitivity to any study medication 3. Presence of any active, known, or suspected autoimmune disorders (including but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, or hypothyroidism); subjects with vitiligo; subjects with asthma requiring medical intervention via bronchodilators 4. Congenital or acquired immunodeficiency disorders (e.g., HIV infection, hepatitis B or C) 5. Prior treatment with PD-1/PD-L1 or CTLA-4 antibodies, or other immunomodulatory receptor-targeting agents 6. Current use of immunosuppressants (subjects in stable condition not requiring systemic immunosuppressive therapy at enrollment may be included) 7. Non-healing wounds or fractures; major surgical procedures or severe traumatic injuries/fractures/ulcers within 4 weeks 8. Clinically significant ascites, pleural effusion, or pericardial effusion requiring therapeutic drainage (subjects with stable effusions after drainage for >=2 weeks prior to treatment may be included) 9. Patients with central nervous system metastases 10. History of other malignancies within 5 years (excluding adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ) 11. Pregnant/lactating women (women of childbearing potential must undergo pregnancy testing; effective contraception is mandated during treatment) 12. Prior pelvic/abdominal radiotherapy 13. Comorbid severe conditions potentially increasing risk or compromising protocol compliance (e.g., unstable cardiac/renal diseases, chronic hepatitis, poorly controlled diabetes, bleeding disorders) 14. History of substance abuse with inability to abstain or psychiatric disorders
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Progression free survival; | — |
Countries
China
Contacts
Public ContactOuyang Yi & Huang Xiaodan
Sun Yat-sen University Cancer Center
Outcome results
None listed