OncoMatch/Clinical Trials/NCT05817214
Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer
Is NCT05817214 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Cadonilimab and Anlotinib for cervical cancer.
Treatment: Cadonilimab · Anlotinib · Granulocyte-Macrophage Colony-Stimulating Factor — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic treatment — first-line
Have only received standard first-line systemic treatment in the past
Cannot have received: anlotinib (anlotinib)
Previous treatment with anlotinib
Cannot have received: cadonilimab (cadonilimab)
Previous treatment with cadonilimab
Lab requirements
Blood counts
WBC ≥3.5×10^9/L, ANC ≥1.5×10^9/L, PLT ≥100×10^9/L, Hb ≥90g/L
Kidney function
blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN, urinary protein <2+ or 24-hour urinary protein quantification <1g
Liver function
ALT and AST ≤2.5 times the upper limit of normal (ULN), bilirubin ≤1.5×ULN, albumin ≥35g/L
Hematological indicators meet the following criteria (not transfused or administered hematopoietic growth factor drugs within the past 7 days): white blood cell count (WBC) ≥3.5×109/L, absolute neutrophil count (ANC) ≥1.5×109/L, platelets (PLT) ≥100×109/L, hemoglobin (Hb) ≥90g/L; Liver function indicators meet the following criteria: ALT and AST ≤2.5 times the upper limit of normal (ULN), bilirubin ≤1.5×ULN, albumin ≥35g/L; Renal function indicators meet the following criteria: blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN, urinary protein <2+ or 24-hour urinary protein quantification <1g
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05817214 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anlotinib, cadonilimab disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages