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 (Jun 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
Treatments studied
Chemotherapy
Other
Cancer type
Cervical Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06209294 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 45 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