Neoadjuvant immunochemotherapy for locally advanced cervical cancer
Official title: Neoadjuvant Immunochemotherapy for Locally Advanced Cervical Cancer: a Prospective, Single-arm, Phase II Clinical Trial
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT07003620 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 34 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 29, 2025 |
| Main results expected | October 30, 2028 |
| Study ends | November 30, 2028 |
| Registry record updated | June 17, 2025 |
| Trial ID | NCT07003620 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.