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

NCT07003620 | Recruiting Phase 2

• 1 other identifier: SYSKY-2024-1115-02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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%.

Conditions

Cervical Cancers

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  3 months post-treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

Intervention Arm

EXPERIMENTAL

Drug: Neoadjuvant immunochemotherapy

Interventions

Neoadjuvant immunochemotherapy DRUG

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Huaiwu Lu

CONTACT

18688395806; luhuaiwu@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: June 4, 2025
• Study Start: June 29, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

CN (1)