NCT06727617 Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors
| NCT ID | NCT06727617 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Cervical Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2024-11-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 134 participants in total. It began in 2024-11-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors
Eligibility 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.
Contact & Investigator
Maobin Meng, Dr.
PRINCIPAL INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Frequently Asked Questions
Who can join the NCT06727617 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cervical Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06727617 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06727617 currently recruiting?
Yes, NCT06727617 is actively recruiting participants. Contact the research team at mmeng@tmu.edu.cn for enrollment information.
Where is the NCT06727617 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06727617 clinical trial?
NCT06727617 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The principal investigator is Maobin Meng, Dr. at Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 134 participants.
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