Short-course radiotherapy with Adebrelimab and platinum chemo before surgery for locally advanced cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm phase II study evaluating the rate of pathological complete response after a neoadjuvant regimen of short-course radiotherapy plus Adebrelimab and platinum chemotherapy, followed by radical hysterectomy with lymphadenectomy. Eligible patients have locally advanced cervical cancer without distant metastasis. The primary endpoint is the pCR rate, assessed by a central pathologist; secondary outcomes are not fully listed. Treatment includes SCRT, three cycles of chemoimmunotherapy, and subsequent surgical removal of affected tissues. The study aims to determine whether this neoadjuvant approach can achieve higher pCR and potentially improve long-term outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qin Qin
• Email: shuizhuqq@njmu.edu.cn
• Phone: +86-15950508512

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• HS-20093 with Adebrelimab vs HS-20093 alone in advanced non-squamous NSCLC

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• Neoadjuvant therapy with adebrelimab, famitinib, and chemotherapy for resectable ESCC

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• A combination therapy for advanced second-line gastric cancer using apatinib with albumin-bound paclitaxel, with or without adebrelimab

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  Recruiting Phase 2 The First Affiliated Hospital of Zhengzhou University · Zhengzhou, Henan · NCT07770113

• Trastuzumab Rezetecan with Adebrelimab and Lenvatinib for advanced HER2-positive/low-expression biliary tract cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.