Serplulimab added to chemoradiotherapy for locally advanced cervical cancer
Tests serplulimab with chemotherapy and radiation in adults with untreated advanced cervical cancer.
Plain-language title generated from the registry record
Registry title: Serplulimab for Locally Advanced Cervical Cancer
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women with locally advanced cervical cancer who have not had any cancer treatment yet. It tests serplulimab added to chemoradiotherapy.
- Age
- 18 to 75 years
- Sex
- Women only
- Disease stage
- Cervical squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma. FIGO 2014 stage IB2-IIB with positive lymph nodes, or stage III-IVA. PD-L1 status does not matter.
- Earlier treatment
- No earlier anti-tumor treatment.
Main reasons for not taking part
- Small cell cervical cancer
- Recurrent cervical cancer or distant metastases
- Active or known autoimmune disease, or active infection
- Another active, untreated cancer within the past 5 years
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07340489, who can take part
Where in China
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tianjin Medical University Cancer Institute and Hospital
- Trial code
- NCT07340489
- Record updated
- 14 January 2026
- Original description
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).Read full original descriptionShow less
Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial
This study is a randomized, controlled, open-label, phase II clinical trial designed to enroll patients with previously untreated locally advanced cervical cancer. The study aims to evaluate the efficacy and safety of adding chemotherapy to serplulimab combined with concurrent chemoradiotherapy. The primary endpoint of this study is progression-free survival (PFS).
Inclusion: Voluntarily willing to participate in the clinical study, fully informed about the study, and signed the informed consent form (ICF); Willing and able to comply with all study procedures; Female aged 18-75 years; ECOG performance status of 0 or 1; PD-L1 status not restricted; Histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; FIGO 2014 (International Federation of Gynecology and Obstetrics) stage IB2-IIB with positive lymph nodes, or stage III-IVA; Patients must meet the following hematologic, renal, and hepatic function criteria:; 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; 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: Prior anti-tumor treatment; Requirement for systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to randomization; Arterial or venous thromboembolic events within 6 months prior to enrollment; Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies; Histologically confirmed small cell cervical cancer; Recurrent cervical cancer or presence of distant metastases; 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; Any active or known autoimmune disease; Active infection; Uncontrolled clinically significant cardiac symptoms or disease; Neurological or psychiatric abnormalities affecting cognitive function; 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; Pregnant or breastfeeding women.