💬In plain words
What the trial is, and whether it could suit you
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:
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📋 Eligibility rules (as published)
Inclusion Criteria:
* Signed informed consent form prior to any study-specific procedure.
Female aged 18 to 80 years (inclusive) at the time of signing informed consent.
Histopathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.
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.
No prior surgery, radiotherapy, or systemic anti-tumor therapy for locally advanced cervical cancer (LACC).
At least one measurable lesion meeting RECIST 1.1 evaluation criteria.
ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.
Adequate hematological, hepatic, and renal function within 14 days prior to enrollment (details to be confirmed in the full protocol).
Exclusion Criteria:
* Pregnant or lactating women, or women who intend to become pregnant during the study period and are unwilling to use effective contraception.
Known hypersensitivity to adebrelimab, platinum-based drugs (cisplatin or carboplatin), or any component of the concomitant regimens.
History of other malignant tumors within 5 years prior to enrollment, except for cured non-melanoma skin cancer or cervical intraepithelial neoplasia.
Uncontrolled severe cardiovascular disease (e.g., NYHA Class III or IV heart failure, unstable angina pectoris, uncontrolled arrhythmias, or myocardial infarction within 6 months).
Active autoimmune disease requiring systemic immunosuppressive or corticosteroid therapy.
Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, or uncontrolled HIV infection.
Uncontrolled severe infection requiring systemic antibiotic/antiviral therapy at enrollment.
Prior participation in other clinical trials and received investigational drug within 4 weeks before enrollment.
Concomitant disease or condition that, in the judgment of the Investigator, would place the subject at undue risk or interfere with the subject's participation in the trial or interpretation of trial results.
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