RecruitingPhase 2NCT07003620

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

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

34 participants

Start Date

Jun 29, 2025

Study Type

INTERVENTIONAL

Conditions

Cervical Cancers

Summary

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%.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving immunotherapy combined with chemotherapy before surgery — called neoadjuvant treatment — can shrink tumors and improve surgical outcomes for women with locally advanced cervical cancer. Researchers hope this approach will make surgery more effective and improve long-term survival rates. **You may be eligible if...** - You have locally advanced cervical cancer (FIGO stages IB3 to IIB) with a primary tumor larger than 4 cm - Your cancer has been confirmed by biopsy as squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma - You have not received any prior cancer treatment - You are in good overall health (ECOG performance status 0 or 1) **You may NOT be eligible if...** - You have a history of other malignant tumors - Your clinical records or treatment history is incomplete - You have severe medical conditions that would prevent follow-up visits or completing treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNeoadjuvant 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.