Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

NCT06727617 | Recruiting Phase 2

• 1 other identifier: E20241188A
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase II Study of Serplulimab Plus Chemoradiotherapy as Adjuvant Treatment for Postoperative Cervical Cancer with Multiple Risk Factors

Conditions

Cervical Cancers

Keywords

cervical cancer; high risk; immunotherapy; radiotherapy

Outcome Measures

Primary Outcomes (1)

• DFS

  The time from the date of random assignment to the first occurrence of locoregional failure, DM, second primary tumor, or death from any cause.

  through study completion, an average of 1 year

Secondary Outcomes (2)

• OS

  through study completion, an average of 1 year

• RFS

  through study completion, an average of 1 year

Study Arms (2)

Serplulimab plus chemoradiotherapy group

EXPERIMENTAL

Serplulimab plus chemoradiotherapy group

Drug: Serplulimab; Drug: Chemotherapy; Radiation: radiotherapy

chemoradiotherapy group

PLACEBO COMPARATOR

chemoradiotherapy group

Drug: Chemotherapy; Radiation: radiotherapy

Interventions

Chemotherapy DRUG

Cisplatin: Administered by intravenous infusion during concurrent chemoradiotherapy at a dose of 30-40 mg/m² once weekly for only 5-6 treatment cycles; during sequential chemoradiotherapy, administered at 60-75 mg/m² on the first and second days of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles. Paclitaxel: Nab-paclitaxel administered by intravenous infusion at a dose of 135-175 mg/m² on the first day of each cycle, once every 3 weeks (21 days) for only 4 treatment cycles.

Serplulimab plus chemoradiotherapy group; chemoradiotherapy group

radiotherapy RADIATION

Pelvic external beam radiation therapy at a dose of 1.8 Gy per fraction or 2 Gy per day, 5 times per week, with a total dose of 45-50 Gy.

Serplulimab plus chemoradiotherapy group; chemoradiotherapy group

Serplulimab DRUG

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)

Serplulimab plus chemoradiotherapy group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Maobin Meng, Dr.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maobin Meng, Dr.

CONTACT

+86 15202231270; mmeng@tmu.edu.cn

Ying Chen, Dr.

CONTACT

+86 13132032398; lychenying2004@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: December 1, 2024
• First Posted: December 11, 2024
• Study Start: November 19, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Locations

CN (1)