Combining Serplulimab with Chemoradiotherapy for High-Risk Postoperative Cervical Cancer
Serplulimab Plus Chemoradiotherapy vs Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer Patients With Multiple Risk Factors: A Randomized, Open-Label, Phase II Clinical Trial
This study is testing if adding the immunotherapy drug Serplulimab to standard chemoradiotherapy can help women with high-risk cervical cancer feel better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | Serplulimab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06727617 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the effectiveness and safety of Serplulimab, an immunotherapy drug, when combined with chemoradiotherapy as an adjuvant treatment for women with postoperative cervical cancer who have multiple risk factors. The study will enroll female patients aged 18 to 65 who have undergone radical surgery and have at least two adverse pathological factors. Participants will be randomly assigned to receive either the combination treatment or chemoradiotherapy alone. The trial aims to determine if the addition of Serplulimab improves patient outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 65 with cervical cancer who have undergone radical surgery and exhibit at least two risk factors.
Not a fit: Patients with early-stage cervical cancer or those without the specified risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and outcomes for patients with high-risk cervical cancer.
How similar studies have performed: While similar approaches combining immunotherapy with chemoradiotherapy have shown promise in other cancers, this specific combination for cervical cancer is still being evaluated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Voluntarily participate in the clinical study: Fully understand and be informed about the study, and sign the informed consent form (ICF); willing to comply with and capable of completing all trial procedures. * Female aged ≥18 years and ≤65 years at the time of signing the ICF. * ECOG PS score of 0 or 1. * Positive PD-L1 status (CPS ≥1). * Diagnosed with cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. * FIGO (International Federation of Gynecology and Obstetrics) stage of IB1, IB2, IIA1, or IIA2, and patients judged by the investigator to benefit from radical surgery and/or adjuvant therapy. * Have undergone radical hysterectomy (Piver classification) and pelvic lymphadenectomy of type II or III. * Postoperative pathological examination confirms at least two adverse factors, which may include: Lymph node metastasis; Positive parametrial or positive resection margins; Lymphovascular space invasion; Deep stromal invasion; * Patients must meet the following hematological, renal, and liver function criteria: Absolute neutrophil count of at least 1.5 × 10⁹/L; Platelet count of at least 100 × 10⁹/L; Total bilirubin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal; Creatinine levels not exceeding the upper limit of normal. * Female participants must have a negative serum pregnancy test within 14 days prior to treatment and agree to use effective contraception during the treatment period and for 6 months afterward; breastfeeding is prohibited during treatment. * Willing and able to comply with the trial and follow-up procedures. Exclusion Criteria: * Patients with unresectable residual tumors. * Histologically confirmed diagnosis of cervical small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma. * Patients who have previously received pelvic radiotherapy. * History of other untreated malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin or carcinoma in situ. * Presence of any active or known autoimmune disease. * History of inflammatory/autoimmune diseases requiring steroid treatment, or currently suffering from inflammatory/autoimmune diseases that require steroid treatment. * Diseases requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization. * History of thromboembolic events (venous or arterial) occurring within 6 months prior to enrollment. * Poorly controlled clinical symptoms or conditions related to heart disease.
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, Dr. — 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.