Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Brief Summary A Phase II Single-Arm Clinical Trial of Short-Course Radiotherapy Combined with Adebrelimab and Platinum-Based Neoadjuvant Therapy for Locally Advanced Cervical Cancer Background \& Objective: This is a single-center, single-arm, Phase II clinical trial. The primary objective is to evaluate the pathological complete response (pCR) rate (defined as ypT0N0) following neoadjuvant therapy with short-course radiotherapy (SCRT) combined with Adebrelimab (an anti-PD-L1 monoclonal antibody) and single-agent platinum chemotherapy in patients with locally advanced cervical cancer (LACC). Study Design: Patients will receive SCRT followed by three cycles of neoadjuvant chemoimmunotherapy. After completion of neoadjuvant treatment, radical hysterectomy with pelvic lymphadenectomy (with or without para-aortic lymphadenectomy) will be performed. Outcome Measures: Primary Endpoint: Pathological Complete Response (pCR) rate assessed by a central pathologist. Secondary Endpoints: Objective Response Rate (ORR) and R0 resection rate (per RECIST 1.1). Event-Free Survival (EFS) and 2-year EFS rate. Incidence and severity of Treatment-Related Adverse Events (TRAEs, per NCI-CTCAE v5.0) and surgical complications (per Clavien-Dindo classification). Feasibility and implementation rate of different adjuvant treatment strategies based on postoperative risk stratification. Depth of response (major pathological response, MPR). Inclusion Criteria: Key eligibility criteria include: Newly diagnosed, histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix. Clinical stage IB3-IIA2 or IIIA (without parametrial invasion) per FIGO 2018 staging. No evidence of extrapelvic lymph node metastasis or distant metastasis (confirmed by PET/CT or enhanced CT). Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-80 lat
- •Potwierdzony rozpoznaniem raka szyjki macicy (komórki płaskonabłonkowe, gruczolakowate lub mieszane)
- •Zaawansowana choroba, stadium IB3-IIA2 lub IIIA bez inwazji parametrium
- •Brak przerzutów do limfatycznych węzłów chłonnych i narządów odległych
- •Brak wcześniejszego leczenia operacyjnego, radioterapii lub chemioterapii
- •Ogólny stan zdrowia dobry (wynik 0-1 w skali ECOG)
- •Prawidłowe wyniki badań krwi, wątroby i nerek
✗ Disqualifies
- •Ciąża lub karmienie piersią
- •Alergia na leki stosowane w badaniu
- •Inne nowotwory w ciągu ostatnich 5 lat
- •Poważne choroby serca (zawał, niestabilna dławica, zaburzenia rytmu)
- •Aktywna choroba autoimmunologiczna wymagająca leków immunosupresyjnych
- •Aktywne wirusowe zapalenie wątroby B lub C, lub niekontrolowana infekcja HIV
- •Poważna infekcja wymagająca antybiotyków lub leków przeciwwirusowych
- •Udział w innym badaniu klinicznym w ostatnich 4 tygodniach
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Last updated (source)
- July 28, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
The Affiliated Hospital of Nanjing Medical University
Nanjing, China
Trial contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/29/2026.
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