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OncoMatch/Clinical Trials/NCT05817214

Cadonilimab Plus Anlotinib for R/M/P Cervical Cancer

Is NCT05817214 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Cadonilimab and Anlotinib for cervical cancer.

Phase 2RecruitingZhongnan HospitalNCT05817214Data as of May 2026

Treatment: Cadonilimab · Anlotinib · Granulocyte-Macrophage Colony-Stimulating FactorThe 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.

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Extracted eligibility criteria

Cancer type

Cervical Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 1 prior line
Min 1 prior line

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.

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