Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
216 participants
INTERVENTIONAL
2025-12-03
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: chemotherapy combined with immunotherapy and radiotherapy
chemotherapy an Serplulimab plus chemoradiotherapy group
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)
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.
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.
Control group: immunotherapy and radiotherapy
Serplulimab plus chemoradiotherapy group
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)
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.
Interventions
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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)
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Maobin Meng
Role: PRINCIPAL_INVESTIGATOR
Tianjin Medical University Cancer Institute and Hospital
Locations
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Tianjin Medical University Cancer Institute & Hospital,
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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E20251312
Identifier Type: -
Identifier Source: org_study_id
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