Recurrent/ metastatic elderly cervical cancer
Conditions
Interventions
Experimental group:Sintilimab in combination with anlotinib and albumin-bound paclitaxel
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
Female
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Written informed consent obtained prior to any trial-related procedures. 2. Female >=65 years old; 3. ECOG PS score of 0-1; 4. Histologically confirmed recurrent or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) that is not suitable for surgery and/or radiotherapy; 5. Positive PD-L1 expression (CPS >= 1%). 6. No prior systemic therapy. 7. Have adequate organ and marrow function, laboratory tests conducted during screening must meet the following criteria: a. Hemoglobin > 7.5 g/dL without blood transfusion or erythropoietin use within the last 14 days; b. Absolute neutrophil count (ANC) >= 1.2×10^9/L without the use of granulocyte colony-stimulating factor within the last 14 days; c. Platelets (PLT) >=7.5×10^9/L without blood transfusion within the last 14 days; d. Total bilirubin (TBIL) = 50mL/min (Cockcroft-Gault formula); g. Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5 times ULN; h. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range; if baseline TSH is out of the normal range, subjects with total T3 (or FT3) and FT4 within the normal range are also eligible; i. Cardiac enzyme spectrum within the normal range (subjects with isolated laboratory abnormalities that are not clinically significant as judged by the investigator are also eligible). 8. Have an estimated survival of more than 3 months. 9. The subject must agree to provide a sufficient tumor tissue sample for PD-L1 expression testing. This includes archived tumor samples (paraffin blocks or unstained slides in a quantity that meets the testing requirements specified in this study); if no archived tumor tissue samples are available, the subject agrees to undergo a re-biopsy of the tumor lesion.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of a malignancy other than cervical cancer within 5 years prior to the first dose (excluding basal cell carcinoma of the skin that has been cured, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been cured by resection); 2. Currently participating in an interventional clinical study treatment, or received other investigational drugs or used investigational devices within 4 weeks prior to the first dose; 3. Prior systemic therapy; 4. Received traditional Chinese medicine or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) with anti-tumor indications within 2 weeks prior to the first dose; 5. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressive agents) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormones, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatment; 6. Receiving systemic corticosteroid therapy (excluding topical, inhaled, or other local routes of corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose in the study; Note: The use of physiologic doses of corticosteroids (=10 mg/day of prednisone or equivalent) is permitted; 7. Active hemoptysis (coughing up at least 2.5 ml or 1/2 teaspoon of bright red blood) within 3 months prior to the first dose of the study drug; 8. Imaging shows tumor invasion/ infiltration of major blood vessels or bleeding tendency assessed by the investigator or radiologist; 9. Major surgical treatment within 4 weeks prior to the first dose of the study drug (excluding surgery for biopsy purposes) or expected to undergo major surgery during the study period; 10. Severe, non-healing wounds, ulcers, or fractures; 11. Underwent minor surgery (outpatient/ inpatient surgery requiring local anesthesia, including central venous catheter placement) within 48 hours prior to the first dose of the study drug; 12. Currently or recently (within 10 days prior to the first dose of the study drug) used aspirin continuously for 10 days (> 325 mg/day) or other nonsteroidal anti-inflammatory drugs known to inhibit platelet function; 13. Currently or recently (within 10 days prior to the first dose of the study drug) used therapeutic doses of oral or parenteral anticoagulants or thrombolytic agents Note: Prophylactic use of low-dose anticoagulants is permitted: Low-dose warfarin (=1mg/d) for prophylactic purposes is allowed with an international normalized ratio (INR) <=1.5, low-dose heparin (<=12,000 U/d), or low-dose aspirin (<=100mg/d); 14. Hereditary bleeding tendency or coagulopathy, or history of thrombosis; 15. Presence of clinically uncontrollable pleural effusion/ ascites (patients who do not require drainage or whose effusion does not significantly increase after stopping drainage for 3 days may be enrolled); 16. Known history of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 17. Known allergy to the active ingredients or excipients of the study drugs sintilimab, anlotinib, or albumin-bound paclitaxel; 18. Not fully recovered from toxicity and/or complications caused by any prior interventions (i.e.,<=Grade 1 or returned to baseline, excluding fatigue or alopecia); 19. Known history of human immunodeficien
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability;Duration of response;Disease control rate;Objective response rate;Overall survival; | — |
Countries
China
Contacts
Public ContactZhu Tao
Zhejiang Cancer Hospital
Outcome results
None listed