Cervical cancer
Conditions
Interventions
Single-arm:Tislelizumab 200 mg, 30 min IV, q3w
Anlotinib 10mg/day, d1~d14, oral before breakfast, taken with warm water, 21d for 1 cycle
Until PD develops, and if the patient does not develop PD, maintenance therapy is continued until disease progression, death, or intolerable chemotherapy toxicity.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research; Fully informed of this study and signed informed consent; Willing to follow and have the ability to complete all trial procedures; 2. Cervical squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma confirmed by histopathology, if there are small cell carcinoma, neuroendocrine carcinoma, sarcoma components, it cannot be enrolled; 3. Patients with recurrent or metastatic cervical cancer who have progressed after first-line or above chemotherapy, or patients with recurrent or metastatic cervical cancer who cannot tolerate chemotherapy; 4. Aged 18-75 years; 5. Presence of at least one measurable lesion according to criteria RECIST1.1, i.e., non-lymph node lesion with a long diameter of >=10 mm, or a lymph node lesion with a short diameter of >=15 mm according to CT cross-sectional imaging or MRI; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; 7. Projected survival for more than 3 months; 8. Organ function and hematopoietic function must meet the following requirements: Hemoglobin (HGB) >=80g/L; White blood cell count (WBC) >= 3×10^9/L; Absolute neutrophil count (ANC) >= 1.5×10^9/L; Platelet count (PLT) >= 80×10^9/L; Total bilirubin (TBIL) =50mL/min International normalized ratio (INR) or plasma prothrombin time (PT) <=1.5×ULN 9. Female subjects of childbearing potential must agree to use effective contraception after signing the informed consent form, during the study, and within 5 months after the last dose of BGB-A317; 10. Subjects must agree to provide blood specimens as well as adequate tumor tissue samples for experimental studies and PD-L1 expression testing. Includes archival tumor samples (paraffin blocks or unstained sections in quantities that meet the testing requirements specified by the Institute); In the absence of an archived tumor tissue sample, the subject agrees to undergo re-biopsy of the tumor lesion.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, or anti-lymphocyte antigen 4 (CTLA-4) antibodies (including ipilimumab or any other antibody or drug that specifically acts on T-cell synergistic stimulation or checkpoint pathways); 2. Received other anti-tumor therapy (including chemotherapy, molecular targeted therapy, radiotherapy, immunotherapy, monoclonal antibody therapy) within 4 weeks prior to the start of study treatment, or participated in other clinical studies of unmarketed drugs; 3. Known subjects who have been allergic to macromolecular protein preparations/monoclonal antibodies, or to any of the components of the test drug in the past; 4. Pregnant or lactating women; 5. Have active autoimmune disease and have received systemic therapy (such as corticosteroids or immunosuppressive drugs) within the past 2 years (such as the following, but not limited to: uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [hypothyroidism without clinical symptoms or hypothyroidism due to chemoradiotherapy can be included]; Subjects with vitiligo or asthma in complete remission in childhood who do not require any intervention in adulthood can be included); 6. Those who need to be treated with systemic corticosteroids (at doses equivalent to or higher than 10mg/day prednisone) or other immunosuppressive drugs within 14 days prior to enrollment or during the study; 7. Those with meningeal metastases or symptomatic central nervous system metastases; 8. Those who have received a live vaccine within 4 weeks prior to the start of treatment; 9. Those who have received anti-tumor vaccines, or anti-tumor therapy with systemic immunostimulatory effects; 10. Patients with serious medical diseases, such as severe infection, uncontrolled diabetes mellitus, cardiovascular disease (grade III or IV heart failure as defined by the New York Heart Association classification, heart block above grade II, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or pulmonary diseases (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm); 11. Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) and deoxyribonucleic acid (HBV DNA) of hepatitis B virus >10^3 copies/ml, or positive for hepatitis C virus antibody; Syphilis-positive patients; 12. Have a history of infection with human immunodeficiency virus, or have other acquired or congenital immunodeficiency diseases; 13. Those with a history of active tuberculosis infection within 1 year prior to enrollment; 14. Patients with other malignant tumors within 5 years prior to enrollment, excluding any type of carcinoma in situ that has been cured before and cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin; 15. Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 16. Those with a history of gastrointestinal perforation or excessive surgical procedure (except for baseline tumor biopsy) or severe trauma, active ulcer, intestinal perforation, intestinal obstruction, fracture not healed within 4 weeks prior to the start of study treatment; 17. History of alcoholism, drug abuse, or substance abuse within the past 1 year; 18. Those who have a clear history of neurological or psychiatric disorde
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Duration of Response;Progression Free Survival;Overall Survival;Evaluation of the safety and tolerability profile of tislelizumab in combination with anlotinib; | — |
Countries
China
Contacts
Public ContactZheng Min
Sun Yat-Sen University Cancer Center
Outcome results
None listed