Serplulimab with chemoradiotherapy, with or without extra chemotherapy, for locally advanced cervical cancer
Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial
This trial tests whether adding induction and consolidation chemotherapy to serplulimab plus concurrent chemoradiotherapy helps women with untreated locally advanced cervical cancer stay cancer-free longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | serplulimab, chemotherapy, immunotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT07340489 on ClinicalTrials.gov |
What this trial studies
This randomized, open-label phase II trial enrolls women with previously untreated locally advanced cervical cancer and randomly assigns them to two treatment arms. The control arm receives serplulimab combined with concurrent chemoradiotherapy followed by maintenance serplulimab for up to two years. The experimental arm adds two cycles of induction chemotherapy and four cycles of consolidation chemotherapy (paclitaxel plus a platinum agent) to the same serplulimab plus chemoradiotherapy backbone. The primary endpoint is progression-free survival as determined by investigators using RECIST v1.1.
Who should consider this trial
Good fit: Women aged 18–75 with previously untreated FIGO 2014 stage IB2–IIB disease with positive lymph nodes or stage III–IVA cervical cancer, ECOG 0–1, adequate blood, liver and kidney function, and no prior anti-tumor treatment are the intended participants.
Not a fit: Patients with early-stage disease, prior systemic or radiation therapy, poor performance status, or significant organ dysfunction would not qualify and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could extend progression-free survival and reduce the risk of recurrence for affected women.
How similar studies have performed: Other early-phase studies combining PD-1/PD-L1 inhibitors with chemoradiotherapy or with chemotherapy in cervical cancer have shown promising signals but have not yet changed standard practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF); 2. Willing and able to comply with all study procedures; 3. Female aged 18-75 years; 4. ECOG performance status of 0 or 1; 5. PD-L1 status not restricted; 6. Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 7. FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA; 8. Patients must meet the following hematologic, renal, and hepatic function criteria: 9. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); Serum creatinine ≤ upper limit of normal (ULN); No prior anti-tumor treatment; Expected survival \> 6 months; 10. Female subjects must have a negative serum pregnancy test within 14 days prior to study treatment, agree to use effective contraception during treatment and for 6 months after treatment, and breastfeeding is prohibited during the study. Exclusion Criteria: 1. Histologically confirmed small cell cervical cancer; 2. Recurrent cervical cancer or presence of distant metastases; 3. Prior anti-tumor treatment; 4. Current or history of another active, untreated malignancy within the past 5 years, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ; 5. Any active or known autoimmune disease; 6. Active infection; 7. Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization; 8. Arterial or venous thromboembolic events within 6 months prior to enrollment; 9. Uncontrolled clinically significant cardiac symptoms or disease; 10. Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies; 11. Pregnant or breastfeeding women; 12. Neurological or psychiatric abnormalities affecting cognitive function; 13. Any other condition or situation that, in the investigator's judgment, would pose a serious risk to the subject's safety, potentially confound study results, or interfere with the subject's ability to complete the study.
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute & Hospital, — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Maobin Meng — Tianjin Medical University Cancer Institute and Hospital
- Study coordinator: Maobin Meng, Dr.
- Email: mmeng@tmu.edu.cn
- Phone: +86 15202231270
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.