NCT06419673Active, not recruitingPhase 2
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer: a Prospective, Multicenter, Randomized, Open Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 17 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 14 May 2024
- Start date
- 1 May 2024
- Primary completion date
- 31 May 2025
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Cervical cancer
- NCT number
- NCT06419673
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 240
- From 1 May 2024 to the primary completion date, 31 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Main Inclusion Criteria:
- Age ≥ 18 years and ≤ 75 years at time of study entry.
- Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
- The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA.
- Diagnosed with PD-L1-positive (combined positive score ≥1).
- Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer.
- WHO/ECOG performance status of 0 or 1.
- Patient must have at least one measurable disease as defined by RECIST 1.1.
- Main Exclusion Criteria:
- 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..
- 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.
- Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
- The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.