OncoMatch/Clinical Trials/NCT07731828
Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial
Is NCT07731828 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Adebrelimab for cervical neoplasms.
Treatment: Adebrelimab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Cancer type
Cervical Cancer
Disease stage
Required: Stage IB3-IIA2, IIIA WITHOUT PARAMETRIAL INVASION (other)
Clinical staging of IB3-IIA2, or IIIA without parametrial invasion (according to FIGO 2018 staging system); no pelvic lymph node metastasis confirmed by PET/CT, and no evidence of distant metastasis
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: surgery for locally advanced cervical cancer
No prior surgery ... for locally advanced cervical cancer (LACC)
Cannot have received: radiotherapy for locally advanced cervical cancer
No prior ... radiotherapy ... for locally advanced cervical cancer (LACC)
Cannot have received: systemic anti-tumor therapy for locally advanced cervical cancer
No prior ... systemic anti-tumor therapy for locally advanced cervical cancer (LACC)
Lab requirements
Blood counts
Adequate hematological function within 14 days prior to enrollment (details to be confirmed in the full protocol)
Kidney function
Adequate renal function within 14 days prior to enrollment (details to be confirmed in the full protocol)
Liver function
Adequate hepatic function within 14 days prior to enrollment (details to be confirmed in the full protocol)
Adequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07731828 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior surgery for locally advanced cervical cancer, radiotherapy for locally advanced cervical cancer, systemic anti-tumor therapy for locally advanced cervical cancer disqualifies patients from enrollment.
What disease stage is eligible?
Stage IB3-IIA2 or IIIA WITHOUT PARAMETRIAL INVASION is required.
Is there an age limit?
Yes. Patients must be 80 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.
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