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Neoadjuvant Short-course Hypofractionated Radiotherapy Plus Adebrelimab and Platinum Chemotherapy in Locally Advanced Cervical Cancer: A Single-arm Phase II Trial

NCT07731828 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Neoplasms

Interventions

DRUG

Adebrelimab

Adebrelimab (1200 mg) is administered intravenously (IV) on Day 1 of each 21-day cycle (Q3W). Neoadjuvant Phase: Patients receive short-course radiotherapy (30 Gy in 6 fractions) concurrent with 2 cycles of Adebrelimab plus platinum-based chemotherapy (cisplatin or carboplatin). Adjuvant Phase: Following surgery, patients receive up to 3 additional cycles of Adebrelimab plus platinum. This is followed by maintenance therapy with Adebrelimab monotherapy (Q3W) for a total treatment duration of 1 year. High-risk patients (positive nodes/margins) may receive additional radiotherapy as clinically indicated.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-01
Completion
2028-08-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07731828 on ClinicalTrials.gov