Neoadjuvant immunochemotherapy for locally advanced cervical cancer
Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
This trial will test whether giving paclitaxel and carboplatin together with a PD‑1/PD‑L1 immune checkpoint inhibitor before definitive treatment helps shrink tumors in patients with locally advanced cervical cancer (FIGO IB3–IIB) with tumors larger than 4 cm.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT07003620 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-arm Phase II trial enrolling treatment‑naïve patients with FIGO stage IB3–IIB cervical cancer and primary tumors greater than 4 cm to receive neoadjuvant paclitaxel plus carboplatin combined with a PD‑1/PD‑L1 inhibitor. The primary endpoint is objective response rate, with secondary endpoints including progression‑free and overall survival and treatment-related adverse events. Tumor biopsies taken before and after therapy will undergo single‑cell RNA sequencing to characterize tumor and immune cell changes associated with response. The study aims to link molecular signatures with clinical outcomes to help tailor personalized neoadjuvant strategies.
Who should consider this trial
Good fit: Ideal candidates are treatment‑naïve adults with histologically confirmed squamous cell carcinoma, adenosquamous carcinoma, or common adenocarcinoma of the cervix, FIGO stage IB3–IIB, primary tumor >4 cm, and ECOG performance status 0–1.
Not a fit: Patients with prior malignancies within the recent past, incomplete clinical data, severe comorbidities, inability to complete follow‑up, or those outside the eligible FIGO stages or tumor size criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could increase preoperative tumor shrinkage, improve long‑term outcomes, and identify biomarkers to personalize therapy.
How similar studies have performed: Early‑phase studies and experience in other tumor types have shown promising responses to combining chemotherapy with PD‑1/PD‑L1 inhibitors, but randomized evidence specifically in locally advanced cervical cancer remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Huaiwu Lu
- Email: luhuaiwu@mail.sysu.edu.cn
- Phone: 18688395806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.