Camrelizumab plus chemotherapy as adjuvant treatment for node-positive stage IIICp cervical cancer
Camrelizumab Combined With Chemotherapy for Adjuvant Treatment of Cervical Cancer Patients With Pathologically Confirmed Lymph Node Positivity After Stage Surgery: A Prospective, Single-Arm, Multicenter, Phase II Clinical Trial
This trial tests whether adding camrelizumab to chemotherapy after radical surgery helps people with PD-L1–positive, node-positive (FIGO2018 IIIC1p/IIIC2p) cervical cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Women's Hospital School Of Medicine Zhejiang University Academic / other |
| Drugs / interventions | camrelizumab, chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07167160 on ClinicalTrials.gov |
What this trial studies
This is a Phase 2 interventional trial of camrelizumab combined with chemotherapy given as adjuvant treatment after radical surgery for patients with pathologically confirmed lymph node–positive cervical cancer. Eligible participants must have FIGO2018 stage IIIC1p or IIIC2p disease, positive PD-L1 expression, and an ECOG score of 0–1. Patients with positive surgical margins, residual lesions, incomplete surgery, active autoimmune disease, or prior immune checkpoint inhibitor treatment are excluded. The study aims to measure the efficacy of the combination regimen in preventing recurrence compared with historical expectations for chemotherapy alone.
Who should consider this trial
Good fit: Ideal candidates are people with FIGO2018 IIIC1p or IIIC2p cervical cancer after complete radical surgery who are PD-L1–positive and have ECOG performance status 0–1 and no prior immune checkpoint inhibitor therapy.
Not a fit: Patients with positive parametrium or surgical margins, incomplete surgery, residual target lesions, active autoimmune disease requiring systemic treatment, prior checkpoint inhibitor therapy, or PD-L1–negative tumors are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, the combination could lower recurrence risk and improve outcomes for PD-L1–positive, node-positive cervical cancer patients after surgery.
How similar studies have performed: Similar approaches using PD-1 inhibitors combined with chemotherapy have shown benefit in PD-L1–positive advanced cervical cancer, so this adjuvant application builds on those findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with cervical cancer staged FIGO2018 IIIC1p or IIIC2p after radical surgery; 2. Positive PD-L1 expression; 3. ECOG score ≤1 Exclusion Criteria: 1. Positive parametrium or surgical margin; 2. Incomplete radical surgery; 3. Residual target lesions; 4. Active autoimmune disease or autoimmune disease requiring systemic treatment; 5. Previous treatment with immune checkpoint inhibitors.
Where this trial is running
Hangzhou, Zhejiang
- Women's Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
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.