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

Официальное название

A Single-arm, Phase II Study of Short-course Hypofractionated Radiotherapy Combined With Adebrelimab and Single-agent Platinum Chemotherapy as Neoadjuvant Therapy for Locally Advanced Cervical Cancer

Обзор

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.

Вмешательства

• Препарат 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

Первичные конечные точки

• Pathological Complete Response (pCR) Rate [Срок оценки: At the time of definitive surgery (approximately 6-8 weeks after completion of neoadjuvant therapy).]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Affiliated Hospital of Nanjing Medical University — Нанкин

Идентификаторы

NCT: NCT07731828 · 2026-SR-411

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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