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

Phase 2

Recruiting

• Conditions: Cervical Cancers
• Interventions: Drug: Neoadjuvant immunochemotherapy

• Registration Number: NCT07003620
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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%.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-05-26
• Status Verified: 2025-06
• Study First Posted: 2025-06-04
• Last Update Submitted: 2025-06-15
• Last Update Posted: 2025-06-17
• Study Start: 2025-06-29
• Primary Completion: 2028-10-30
• Study Completion: 2028-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

Inclusion 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.
• ECOG performance status of 0-1.
• no prior treatment.

Exclusion Criteria

• Patients with a history of other malignant tumors in the past.
• Patients whose clinical data or treatment information is incomplete.
• Patients with severe comorbidities or those who cannot complete follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Neoadjuvant immunochemotherapy	-

Primary Outcome Measures

Name	Time	Method
Objective response rate	3 months post-treatment

Secondary Outcome Measures

Name	Time	Method
Overall survival	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	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	From the initiation of treatment until 30 days after the last dose of neoadjuvant immunochemotherapy

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou; 🇨🇳 Guangzhou, Guangdong, China