NCT07340489

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for phase_2

Timeline
19mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Nov 2027

Study Start

First participant enrolled

December 3, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

January 14, 2026

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

January 6, 2026

Last Update Submit

January 6, 2026

Conditions

Cervical Cancer

Keywords

cervical cancerimmunotherapychemoradiotherapy

Outcome Measures

Primary Outcomes (2)

  • PFS

    defined as the time from randomization to the first occurrence of disease progression or death from any cause.

    through study completion, an average of 2 year

  • OS

    The time from random assignment to death because of any cause.

    through study completion, an average of 2 year

Secondary Outcomes (1)

  • safety assessment

    through study completion, an average of 2 year

Study Arms (2)

Experimental: chemotherapy combined with immunotherapy and radiotherapy

EXPERIMENTAL

chemotherapy an Serplulimab plus chemoradiotherapy group

Drug: SerplulimabRadiation: radiotherapyDrug: Chemotherapy

Control group: immunotherapy and radiotherapy

PLACEBO COMPARATOR

Serplulimab plus chemoradiotherapy group

Drug: SerplulimabRadiation: radiotherapy

Interventions

ChemotherapyDRUG

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.

Experimental: chemotherapy combined with immunotherapy and radiotherapy
SerplulimabDRUG

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)

Control group: immunotherapy and radiotherapyExperimental: chemotherapy combined with immunotherapy and radiotherapy
radiotherapyRADIATION

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.

Control group: immunotherapy and radiotherapyExperimental: chemotherapy combined with immunotherapy and radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Histologically confirmed small cell cervical cancer;
  • Recurrent cervical cancer or presence of distant metastases;
  • Prior anti-tumor treatment;
  • 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;
  • 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;
  • Uncontrolled clinically significant cardiac symptoms or disease;
  • Known allergy to the investigational drug or any of its excipients, or prior severe allergic reaction to other monoclonal antibodies;
  • Pregnant or breastfeeding women;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital,

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

RadiotherapyDrug Therapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Maobin Meng

    Tianjin Medical University Cancer Institute and Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maobin Meng, Dr.

CONTACT

+86 15202231270mmeng@tmu.edu.cn

Ying Chen, Dr.

CONTACT

+86 13132032398lychenying2004@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 14, 2026

Study Start

December 3, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

January 14, 2026

Record last verified: 2025-12

Locations

CN(1)