Recurrent or metastatic cervical cancer progressing after immunotherapy
Conditions
Interventions
Dual immunotherapy combined with earplug noise reduction intervention group:Atezolizumab plus anti-PD-L1 antibody (5mg/kg Q3W) combined with earplug noise reduction intervention (worn during infusion)
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed persistent, recurrent, or metastatic cervical cancer, with histological types of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 2. Not suitable for curative treatments including surgery, radiotherapy, concurrent chemoradiotherapy, etc.; 3. Prior treatment with PD-1/PD-L1 inhibitors and radiological progression (RECIST 1.1: PD) documented; 4. At least one measurable lesion as confirmed by RECIST 1.1 criteria; 5. Age: 18 to 75 years; 6. ECOG performance status: 0 to 1; 7. Expected survival > 3 months; 8. Able to cooperate with earplug wearing and follow-up assessments; 9. Planned to receive Aituo combination antibody therapy; 10. Adequate major organ function, meeting the following criteria: (1) Hematology (without blood transfusion or growth factor support within 14 days prior to screening): hemoglobin (HGB) >= 90 g/L; absolute neutrophil count (NEUT) >= 1.5 × 10^9/L; platelet count (PLT) >= 100 × 10^9/L; (2) Biochemistry: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 60 mL/min; (3) Coagulation: activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) = 50%; 11. Female subjects of childbearing potential must agree to use contraceptive measures (such as intrauterine device, contraceptives, or condoms) during the study and for 6 months after study completion; serum pregnancy test must be negative within 7 days prior to enrollment, and subjects must not be lactating; 12. Patients voluntarily participate in this study, sign informed consent, and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Presence of the following diseases or medical history: (1) Other malignancies occurring within 5 years or currently coexisting. The following two conditions allow enrollment: other malignancies treated with surgery alone, achieving R0 resection with no evidence of recurrence or metastasis; cured non-melanoma skin cancer, nasopharyngeal carcinoma, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invades basement membrane)]; (2) Pathological findings indicating other special histological types such as mucinous adenocarcinoma, clear cell adenocarcinoma, neuroendocrine tumors, etc.; (3) Unresolved toxicities from any prior therapy higher than CTC AE grade 1, excluding alopecia and peripheral sensory neuropathy; (4) Major surgical procedure or significant traumatic injury (excluding diagnostic puncture, endoscopic biopsy, etc.) within 28 days before the start of study treatment; (5) Long-standing non-healing wounds or bone fractures; (6) Arterial/venous thrombotic events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; (7) History of substance abuse with psychoactive drugs that cannot be abstained from, or presence of mental disorders; (8) Subjects with any severe and/or uncontrolled disease, including: 1) Inadequate blood pressure control after standard therapy (systolic blood pressure >=150 mmHg or diastolic blood pressure >=100 mmHg); 2) Myocardial ischemia or myocardial infarction within 6 months; congestive heart failure of NYHA class >=2; atrioventricular block >= grade 2; arrhythmias that cannot be stably controlled with medication (including QTc >=470 ms) and arrhythmias that may have potential impact on the study treatment; 3) Active infection (>= CTC AE grade 2 infection); 4) Decompensated liver cirrhosis, active hepatitis*; * Active hepatitis (reference for hepatitis B: HBsAg positive and HBV DNA >2500 copies/mL or >500 IU/mL; reference for hepatitis C: HCV antibody positive and HCV viral titer above the upper limit of normal); Note: For subjects with positive HBsAg or positive HBcAb, and hepatitis C patients who meet enrollment criteria, continuous antiviral therapy is recommended to prevent viral reactivation; 5) Known active syphilis or active tuberculosis; 6) Renal failure requiring hemodialysis or peritoneal dialysis: eGFR 10 mmol/L; 9) Urinalysis showing urine protein >=++, and confirmed 24-hour urine protein quantification >1.0 g; 10) Epilepsy requiring treatment; 11) Previous or current interstitial pneumonia, (non-infectious) pneumonia requiring corticosteroid treatment, or currently having other types of pneumonia >= grade 2. 2. Tumor-related symptoms and treatments: (1) Received surgery, radiotherapy, or other anti-cancer therapies within 4 weeks before the start of study treatment (washout period calculated from the end of the last treatment); for those who have received prior local radiotherapy, enrollment is allowed if: radiotherapy ended more than 4 weeks (or more than 2 weeks for brain radiotherapy) before the start of study treatment; and the target lesion selected for this study is not within the radia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate, ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Incidence of adverse events;Quality of life score;6-month progression-free survival rate;Progression-free survival, PFS;Changes in exploratory biomarkers;Duration of response, DOR;Disease control rate, DCR; | — |
Countries
China
Contacts
Public ContactXu Qin
Fujian Cancer Hospital
Outcome results
None listed