Cervival Cancer
Conditions
Interventions
Experimental group:Carrelizumab IV 200mg, every 3 weeks/cycleFamitinib PO 10mg QD, every 3 weeks/cycleTP double drug chemotherapy for 3 cycles
Sponsors
Fujian Cancer Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years; 2. Pathologically confirmed cervical squamous carcinoma, adenocarcinoma, or adenocarcinoma staged as IB3, IIA2, IIB, IIIC1 (diameter >= 4cm) according to FIGO (2018); 3. ECOG score of 0-1; 4. Availability of pathological specimens (>= 18 qualified tissue slides) for biomarker testing; 5. No prior surgeries (excluding staging surgeries), radiotherapy, chemotherapy, systemic treatments (including experimental drugs), or immunotherapy specifically targeting cervical cancer; 6. At least one measurable lesion (according to RECIST 1.1 criteria, tumor lesion CT scan longest diameter >= 10mm, lymph node lesion CT scan shortest diameter >= 15mm); 7. Expected survival time >= 6 months; 8. No primary or metastatic central nervous system diseases; 9. Major organ functions are normal, and blood routine examination standards must meet the following (no blood transfusions or blood products within 14 days): Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L; Platelets (PLT) >= 80 × 10^9/L; Hemoglobin (HGB) >= 9 g/dL. Biochemical tests must meet standards: Liver function: Serum total bilirubin (TBIL) = 40 mL/min (using the standard Cockcroft-Gault formula); 10. The subject has signed the informed consent and is cooperating with follow-up.
Exclusion criteria
Exclusion criteria: 1. Researchers believe that they are not suitable for inclusion; 2. Allergies to any drugs in the study; 3. Presence of any active, known, or suspected autoimmune diseases (such as, but not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, pituitary inflammation, hyperthyroidism, hypothyroidism, etc.); subjects having vitiligo; subjects requiring bronchodilators for medical intervention for asthma; 4. Subjects with congenital or acquired immune deficiencies (such as HIV infection, hepatitis B, hepatitis C); 5. Subjects previously treated with other PD-1 and/or PD-L1 or CTLA-4 antibody therapies, or other drug treatments targeting immune regulatory receptors; 6. Subjects using immunosuppressants, stable at the time of enrollment, who do not require systemic immunosuppressive therapy; 7. Long-term untreated wounds or fractures; major surgery or severe traumatic injuries, fractures, or ulcers within the past 4 weeks; 8. Patients with uncontrolled cardiac clinical symptoms or diseases, classified as NYHA III-IV heart failure, or those with an echocardiogram indicating a left ventricular ejection fraction (LVEF) 1.5, APTT > 1.5 ULN), having a bleeding tendency, or those who have had episodes of venous thromboembolism within the last 6 months (up to the initial administration of study medication); 9. Patients with clinically symptomatic ascites, pleural effusion, or pericardial effusion requiring therapeutic puncture or drainage, who have been stable for at least 2 weeks after drainage before the first administration of study medication can be included in the study; 10. Patients with central nervous system metastases; 11. Patients with a history of other malignancies, except for cured skin basal cell carcinoma and carcinoma in situ of the cervix; 12. Pregnant or nursing women; 13. Patients with a history of substance abuse involving psychoactive drugs who are unable to withdraw or have mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease remission rate;Disease control rate ;Progression-free survival ;Overall survival;Duration of response;Time to response;Time to first disease progression;Quality of life;Rate of brachytherapy dose reduction;All adverse events ;Adverse events during treatment;Serious adverse events; | — |
Countries
China
Contacts
Public ContactQin Xu
Fujian Cancer Hospital
Outcome results
None listed