Trial · NCT06419673
Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
NCT06419673, Phase 2, Active not recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer. Trials, record NCT06419673. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06419673
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer
- NCT number
- NCT06419673
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Conditions
- Cervical Cancer
- Interventions
- Serplulimab, Cisplatin, Carboplatin, Brachytherapy and External Beam Radiotherapy
- First posted
- 2024-05-17
- Last updated
- 2024-05-17
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Secondary | Overall Survival (OS) at Month 36 | Up to approximately 46 months | Overall Survival (OS) at Month 36 \[ Time Frame: Up to approximately 46 months \] OS, defined as the time from initiation of study treatment to death from any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months. |
| Secondary | Objective Response Rate (ORR) | Baseline up to approximately 36 months | ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1. |
| Secondary | Complete Response Rate(CRR) | Baseline up to approximately 36 months | The rate of CR (Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to \<10mm). |
| Secondary | Time to the first disease progression (TTP) | Up to approximately 24 months | Ddefined as the interval between the date of the initial medication and the time of imaging progression. |
| Secondary | Duration of response (DOR) | Up to approximately 24 months | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06419673
GET https://conductscience.org/api/trials/v1/NCT06419673/registered