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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou
RECRUITING
Guangzhou
Contact Information
Primary
Huaiwu Lu
luhuaiwu@mail.sysu.edu.cn
18688395806
Time Frame
Start Date: 2025-06-29
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 34
Treatments
Experimental: Intervention Arm
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

This content was sourced from clinicaltrials.gov