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RECRUITING

NCT07340489

PHASE2

Serplulimab for Locally Advanced Cervical Cancer

Sponsor: Tianjin Medical University Cancer Institute and Hospital

View on ClinicalTrials.gov

Summary

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).

Official title: Chemoradiotherapy Combined With Serplulimab for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized, Phase II Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

216

Start Date

2025-12-03

Completion Date

2027-11-30

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Cervical Cancer

Interventions

DRUG

Serplulimab

intravenous infusion of 300 mg, administered every 3 weeks as one cycle, on the first day of each cycle, with a maximum treatment duration of 2 years (up to 35 treatment cycles)

RADIATION

radiotherapy

Pelvic external beam radiotherapy was delivered with a prescribed dose of 45.0-50.4 Gy in 25-28 fractions to the PTV, administered once daily, five days per week; the PGTVnd received a simultaneous integrated boost to 53.50-59.92 Gy in 25-28 fractions. During radiotherapy, concurrent chemotherapy with weekly cisplatin was administered. Brachytherapy was delivered with 28 Gy in 4 fractions, prescribed to the 100% isodose line covering the CTV.

DRUG

Chemotherapy

Two cycles of induction chemotherapy were administered prior to concurrent chemoradiotherapy, consisting of cisplatin 60-75 mg/m² on days 1 and 2 of each cycle, once every 3 weeks (21 days), and nab-paclitaxel 135-175 mg/m² by intravenous infusion on day 1 of each cycle, once every 3 weeks (21 days). After completion of concurrent chemoradiotherapy, patients received four cycles of consolidation chemotherapy using the same cisplatin and nab-paclitaxel regimen as above.

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.

Locations (1)

Tianjin Medical University Cancer Institute & Hospital,

Tianjin, Tianjin Municipality, China