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Serplulimab With Chemoradiotherapy for Postoperative Cervical Cancer With Risk Factors

ConditionCervical Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • 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.

  • 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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Serplulimab plus chemoradiotherapy groupExperimental treatment 3 interventions
Group B: chemoradiotherapy groupPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

OS

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

Time frame
through study completion, an average of 1 year
2

RFS

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

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tianjin Medical University Cancer Institute and Hospital

Lead sponsor

Source ClinicalTrials.gov
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