OncoMatch/Clinical Trials/NCT06209294
Phase II Study on Neoadjuvant Therapy of AK104 Combined With Nab-paclitaxel/Carboplatin in Fertility Preserving Surgery
Is NCT06209294 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AK104 and Carboplatin for neoadjuvant immunotherapy.
Treatment: AK104 · Carboplatin · Nab paclitaxel — This is a Phase II study of neoadjuvant therapy of AK104 combined with nab-paclitaxel/carboplatin in fertility saving surgery for stage IB2-IB3 cervical cancer (FIGO 2018). The main questions it aims to answer are: * · Evaluate the safety of AK104 combined with nab-paclitaxel/carboplatin in the neoadjuvant treatment of cervical cancer * · Evaluate the tumor regression and Major Pathological Response(MPR) of AK104 combined with nab-paclitaxel/carboplatin as neoadjuvant therapy for cervical cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Cannot have received: chemotherapy
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Cannot have received: immunotherapy
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Cannot have received: biological agent
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Cannot have received: small molecule targeted therapy
Have not received any systemic or local anti-tumor treatment for cervical cancer before the first medication, including radiotherapy, chemotherapy, immunotherapy, biological agents, small molecule targeted therapy, etc.
Lab requirements
Blood counts
ANC ≥ 1.5 × 10^9/L (1,500/mm3); Platelet count ≥ 100 × 10^9/L (100,000/mm3); Hemoglobin ≥ 90 g/L
Kidney function
Calculated creatinine clearance (CrCl) ≥ 50 mL/min; Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g
Liver function
Serum total bilirubin (TBil) ≤ 1.5 × ULN; AST and ALT ≤ 2.5× ULN; Serum albumin (ALB) ≥ 28 g/L
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
With good organ function: Hematology: ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 90 g/L. Kidney: CrCl ≥ 50 mL/min; Urine protein < 2+ or 24-hour urine protein quantification < 1.0 g. Liver: TBil ≤ 1.5 × ULN; AST and ALT ≤ 2.5× ULN; ALB ≥ 28 g/L. Coagulation: INR and APTT ≤ 1.5 × ULN. Heart: LVEF ≥ 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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