Serplulimab: Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Cisplatin: IV infusion
Carboplatin: IV infusion
Brachytherapy and External Beam Radiotherapy: Brachytherapy and External Beam Radiotherapy
Study summary
This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Main Inclusion Criteria:
1. Age ≥ 18 years and ≤ 75 years at time of study entry.
2. Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
3. The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA.
4. Diagnosed with PD-L1-positive (combined positive score ≥1).
5. Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer.
6. WHO/ECOG performance status of 0 or 1.
7. Patient must have at least one measurable disease as defined by RECIST 1.1.
Main Exclusion Criteria:
1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent o..
2. Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study.
3. Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
4. The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
Primary outcome measure(s)
Progression-Free Survival(PFS) at Month 36 — Up to approximately 46 months. PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 36 using the entire PFS data up to the cut-off date.
Trial sites (1)
Facility
City
Region
Status
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
More Cancer Institute and Hospital, Chinese Academy of Medical Sciences trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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