Идёт набор NCT07003620

Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial

Фаза II С лечением Cervical Cancers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Neoadjuvant immunochemotherapy.
Кому может быть актуально: Состояния в реестре: Cervical Cancers. Базовые параметры: 18 лет — 80 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This is a prospective, single-arm, Phase II clinical trial designed to evaluate the efficacy and safety of paclitaxel and carboplatin combined with PD-1/PD-L1 immune checkpoint inhibitors in the treatment of locally advanced cervical cancer. Using single-cell RNA sequencing (scRNA-seq), the study aims to investigate the molecular mechanisms underlying differential treatment responses and optimize personalized therapeutic strategies. Eligibility Criteria: Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter \>4 cm will be enrolled. All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, an ECOG performance status of 0-1, and no prior treatment. Outcome Measures: * Primary endpoint: Objective response rate (ORR), assessing tumor regression. * Secondary endpoints:Overall survival (OS), progression-free survival (PFS), and incidence of treatment-related adverse events (graded by CTCAE criteria). * Exploratory endpoint:\*\* Impact of treatment on the tumor microenvironment and gene expression profiles. Study Intervention: All patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis. Sample Size: The study plans to enroll at least 34 eligible patients. Based on treatment response, patients will be categorized into high-response and low-response groups, with a minimum of 5 cases per group selected for scRNA-seq to ensure robust molecular mechanism analysis. The sample size calculation assumes a historical ORR of 65% and a target ORR of 85%.

Вмешательства

Препарат Neoadjuvant immunochemotherapy
All patients will receive three cycles of paclitaxel and carboplatin chemotherapy combined with PD-1/PD-L1 inhibitor therapy, followed by open radical hysterectomy and pelvic lymphadenectomy. Postoperative adjuvant therapy (chemotherapy, chemoradiation, or maintenance immunotherapy) will be determined based on pathological assessment. Tumor tissue samples will be collected during treatment for single-cell sequencing analysis.

Первичные конечные точки

Objective response rate [Срок оценки: 3 months post-treatment]

Вторичные конечные точки (3)

Overall survival [Срок оценки: From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of death from any cause), assessed up to 3 years]
progression-free survival [Срок оценки: From the initiation of treatment (first dose of neoadjuvant immunochemotherapy) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years]
incidence of treatment-related adverse events [Срок оценки: From the initiation of treatment until 30 days after the last dose of neoadjuvant immunochemotherapy]

Критерии участия

Критерии включения

Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter >4 cm will be enrolled.
All patients must have histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma.
ECOG performance status of 0-1.
no prior treatment.