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Trial Title:
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
NCT ID:
NCT06419673
Condition:
Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Carboplatin
Conditions: Keywords:
Serplulimab
Concurrent chemoradiotherapy
Cervical Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Serplulimab
Description:
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.
Arm group label:
Serplulimab + chemoradiotherapy , Serplulimab maintenance
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
IV infusion
Arm group label:
Concurrent chemoradiotherapy
Arm group label:
Serplulimab + chemoradiotherapy , Serplulimab maintenance
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
IV infusion
Arm group label:
Concurrent chemoradiotherapy
Arm group label:
Serplulimab + chemoradiotherapy , Serplulimab maintenance
Intervention type:
Radiation
Intervention name:
Brachytherapy and External Beam Radiotherapy
Description:
Brachytherapy and External Beam Radiotherapy
Arm group label:
Concurrent chemoradiotherapy
Arm group label:
Serplulimab + chemoradiotherapy , Serplulimab maintenance
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.
Detailed description:
Cervical cancer is the most prevalent malignant tumor of the female reproductive system
in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent
chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical
cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year
progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival
(OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18
study demonstrated that the combination of pembrolizumab and CRT reduced the progression
risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this,
the FDA approved pembrolizumab in combination with CRT for the treatment of newly
diagnosed stages III-IVA cervical cancer in January 2024. This prospective, multicenter,
randomized, controlled clinical trial study aims to evaluate the effectiveness and safety
of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA
cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma
patients who have not received prior treatment.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Start date:
May 1, 2024
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class:
Other
Source:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06419673
