Actively Recruiting
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-06-17
34
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining paclitaxel and carboplatin chemotherapy with PD-1/PD-L1 immune checkpoint inhibitors for treating locally advanced cervical cancer. This Phase II, single-arm study focuses on patients with cervical cancer stages IB3 to IIB and aims to better understand treatment responses at the molecular level using single-cell RNA sequencing. The study is sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. All participants will receive three cycles of neoadjuvant immunochemotherapy with paclitaxel, carboplatin, and a PD-1/PD-L1 inhibitor. After chemotherapy, patients will undergo open radical hysterectomy and pelvic lymphadenectomy surgery. Postoperative adjuvant therapy, including chemotherapy, chemoradiation, or maintenance immunotherapy, will be decided based on pathological results. Tumor tissue samples will be collected during treatment for detailed molecular analysis. Participants will be closely monitored through tumor assessments to measure the objective response rate three months after treatment. Secondary outcomes include overall survival, progression-free survival up to three years, and treatment-related side effects. The study plans to enroll at least 34 patients who meet the eligibility criteria. Tissue samples from high and low treatment responders will undergo molecular sequencing to investigate the tumor microenvironment and gene expression changes, helping to optimize personalized therapies.
CONDITIONS
Brief Title
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with locally advanced cervical cancer (FIGO stages IB3 to IIB) and a primary tumor diameter >4 cm
- Histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma
- ECOG performance status of 0-1
- No prior treatment for cervical cancer
You will not qualify if you...
- History of other malignant tumors in the past
- Incomplete clinical data or treatment information
- Severe comorbidities or inability to complete follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants 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 is determined based on pathological assessment.
Multiple visits for chemotherapy cycles and surgery
Duration - Up to 3 years
Participants are monitored for treatment-related adverse events for 30 days after the last dose of neoadjuvant immunochemotherapy, and survival outcomes are assessed up to 3 years.
Periodic visits for assessments
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
H
Huaiwu Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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