About this trial
The goal of this clinical trial is to test a new treatment combination including cadonilimab, anlotinib and granulocyte-macrophage colony-stimulating factor (GM-CSF) in recurrent, metastasis and persistent cervical cancer. The main questions it aims to answer are:
* The efficacy of this combination in R/M/P CC; * The tolerance of this combination in R/M/P CC; * Possible biomarker of treatment response for this combination.
Participants will receive cadonilimab of 10mg/kg every three weeks at day 1, take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break and subcutaneously injection of GM-CSF (200ug) from day 1 to day 14, then also take a 7-days break. This treatment will continue until progression or intolerable toxicity or withdraw of participants and it will last for no longer than 2 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Obtain informed consent signed by the patient or their legal representative;
Female patients aged ≥18 and ≤75 years old;
ECOG PS score of 0-1;
Expected survival period ≥6 months;
Disqualifiers
Any unstable systemic diseases, including but not limited to active infections within 4 weeks (defined as fever exceeding 38.5°C, evidence of bacteremia, or evidence of infectious changes in the heart, brain, kidneys, lungs, liver, and intestines), circulatory accidents within 6 months (malignant hypertensive crisis, myocardial infarction, severe/unstable angina, heart failure above NYHA class 2, clinically significant supraventricular or ventricular arrhythmias, or cerebral vascular accidents not yet recovered from or resulting in severe sequelae), uncontrolled type 2 diabetes (fasting blood glucose >11.1 mmol/L or glycated hemoglobin >8%), and pulmonary insufficiency (any cause leading to decreased lung function, defined as FEV1/FVC <70%, FEV1 <80% of predicted value).
History of autoimmune diseases, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, autoimmune liver diseases, systemic vasculitis, scleroderma, dermatomyositis, autoimmune hemolytic anemia;
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; hepatitis C, defined as HCV-RNA higher than the detection limit of the assay) or combined hepatitis B and hepatitis C infection;
History of attenuated live vaccine administration within 28 days before the first dose of the study drug or expected attenuated live vaccine administration during the study period;
Trial design
Single group
Treatments tested in this trial
Cadonilimab
DrugAll Participants will receive cadonilimab of 10mg/kg every three weeks at day 1
Anlotinib
DrugAll Participants will take anlotinib (12mg) orally in day 1 to day 14, then take a 7 days break.
Granulocyte-Macrophage Colony-Stimulating Factor
DrugAll Participants will have subcutaneously injection of granulocyte-macrophage colony-stimulating factor from day 1 to day 14, then take a 7 days break.
Treatment groups
Trial outcomes
Primary outcomes
Objective response rate
Rate of participants with complete response plus partial response as best response in the intent to treatment group according to RECIST 1.1
Secondary outcomes
Rate and grade of adverse events
The incidence of adverse events and severity graded according to CTCAE 5.0
Disease control rate
Rate of participants with complete response plus partial response plus stable disease as best response in the intent to treatment group according to RECIST 1.1
Duration of Response
Time period from first response to first progression
Progression free survival rate
Proportion of participants without tumor recurrence or death
Sponsors and contacts
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Zhongnan Hospital
Lead sponsor
Akeso Biopharma Co., Ltd.
Collaborator