Chemotherapy with immune drugs before surgery for cervical cancer
Tests paclitaxel, carboplatin and immune checkpoint inhibitors before surgery in cervical cancer.
Plain-language title generated from the registry record
Registry title: Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 80 with locally advanced cervical cancer who have not been treated before and have a primary tumor larger than 4 cm (1.6 in).
- Age
- 18 to 80 years
- Sex
- Women only
- Disease stage
- Locally advanced cervical cancer, FIGO stages IB3 to IIB, primary tumor diameter >4 cm (1.6 in). Squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma, confirmed by tissue examination.
- Earlier treatment
- No prior treatment.
Main reasons for not taking part
- A history of other malignant tumors in the past
- Incomplete clinical data or treatment information
- Severe comorbidities
- Cannot complete follow-up
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07003620, who can take part
Where in China
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University, GuangzhouGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT07003620
- Record updated
- 17 June 2025
- Original description
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.Read full original descriptionShow less
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
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%.
Inclusion: 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: 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.