Clinical trial · Interventional
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
NCT06419673CI-TRIAL-00077279active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brachytherapy and External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Serplulimab | Drug | Serplulimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Serplulimab + chemoradiotherapy , Serplulimab maintenance
- description
- Participants receive serplulimab 300 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W) for 3 cycles followed by serplulimab 300 mg IV on Day 1 of each 6-week cycle (Q3W) for an additional 15 cycles. During the Q3W dosing period of serplulimab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.
- interventionNames
- Drug: Serplulimab
- Drug: Cisplatin
- Drug: Carboplatin
- Radiation: Brachytherapy and External Beam Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy
- description
- Participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV or carboplatin (AUC=2) once per week (QW) for 5 or 6 weeks plus external beam radiotherapy followed by brachytherapy not to exceed 8 weeks.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.