Neoadjuvant Finotonlimab Plus TP Regimen in Locally Advanced INI-1-Deficient Sinonasal Carcinoma
NCT07927465, Phase 2, Recruiting, Eye & ENT Hospital of Fudan University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Neoadjuvant Finotonlimab Plus TP Regimen in Locally Advanced INI-1-Deficient Sinonasal Carcinoma | ClinicalTrials.gov |
| NCT number | NCT07927465 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Eye & ENT Hospital of Fudan University | ClinicalTrials.gov |
| Conditions | SMARCB1-Deficient Sinonasal Carcinoma | ClinicalTrials.gov |
| Interventions | Finotonlimab, Paclitaxel, Cisplatin | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Objective Response Rate | After completion of 2 cycles of neoadjuvant therapy (each cycle is 21 days; response assessment performed approximately 3 weeks after the last dose of cycle 2) | Objective response rate (ORR) is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) after 2 cycles of neoadjuvant finotonlimab plus TP chemotherapy. Tumor response is assessed by contrast-enhanced MRI of the skull base and chest CT, and evaluated by a blinded independent central review (BICR) according to RECIST v1.1. ORR is calculated as (CR + PR) divided by the number of participants in the full analysis set (all enrolled participants who signed informed consent and received at least 1 dose of study treatment). The 95% confidence interval will be estimated using the Clopper-Pearson exact method. | ClinicalTrials.gov |
| Secondary | Disease Control Rate (DCR) | Approximately 9 weeks after the first dose of neoadjuvant therapy (after 2 cycles of 21 days each), consistent with the primary ORR assessment time point. | DCR is defined as the proportion of participants who achieve complete response (CR), partial response (PR), or stable disease (SD) after 2 cycles of neoadjuvant finotonlimab plus TP chemotherapy, assessed by blinded independent central review (BICR) using RECIST v1.1. DCR is calculated as (CR + PR + SD) divided by the number of evaluable participants. | ClinicalTrials.gov |
| Secondary | R0 Resection Rate | At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy) | R0 resection rate is defined as the proportion of participants who undergo surgery and achieve microscopically negative surgical margins (R0), as confirmed by central pathology review. The denominator is all participants who undergo definitive surgery. | ClinicalTrials.gov |
| Secondary | Disease-Free Survival (DFS) | From the date of surgery until the date of first documented recurrence, metastasis, or death from any cause, assessed up to 3 years after surgery. | DFS is defined as the time from the date of surgery to the date of local recurrence, distant metastasis, or death from any cause, whichever occurs first. DFS will be estimated using the Kaplan-Meier method. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From the date of enrollment until the date of death from any cause, assessed up to 3 years after enrollment. | OS is defined as the time from enrollment (or randomization, if applicable) to the date of death from any cause. Participants alive at the last follow-up will be censored at that date. OS will be estimated using the Kaplan-Meier method. | ClinicalTrials.gov |
| Secondary | Major Pathological Response (MPR) Rate | At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy). | MPR is defined as the proportion of participants whose surgically resected specimens contain ≤10% viable tumor cells, as assessed by central pathology review. The denominator is all participants who undergo definitive surgery and have evaluable pathological specimens. | ClinicalTrials.gov |
| Secondary | Pathological Complete Response (pCR) Rate | At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy). | pCR is defined as the proportion of participants whose surgically resected specimens contain no viable tumor cells, as assessed by central pathology review. The denominator is all participants who undergo definitive surgery and have evaluable pathological specimens. | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Adverse Events During Neoadjuvant Therapy | From the first dose of neoadjuvant therapy until 30 days after the last dose of neoadjuvant therapy (approximately 3 months). | All adverse events (AEs), Grade ≥3 AEs, and serious adverse events (SAEs) occurring during neoadjuvant therapy will be recorded and graded according to CTCAE v5.0. The type, incidence, and outcome of each event will be summarized descriptively. | ClinicalTrials.gov |
| Secondary | Incidence of Surgery- and Radiotherapy-Related Complications | From the date of surgery until 12 months after completion of postoperative radiotherapy. | The incidence of prespecified complications will be recorded, including cerebrospinal fluid leak, intracranial infection, cranial nerve injury, major hemorrhage, trismus, and radiation-induced brain injury. Complications will be documented from the surgical record and during the postoperative radiotherapy and follow-up periods | ClinicalTrials.gov |
| Secondary | Change in Quality of Life Scores Assessed by EORTC QLQ-C30 and QLQ-H&N35 | Baseline, before surgery (after neoadjuvant therapy), after surgery, and every 6 months during follow-up, assessed up to 3 years after enrollment. | Quality of life will be assessed using the EORTC QLQ-C30 (Version 3.0) and the head and neck module QLQ-H\&N35. Scores for functional scales, symptom scales, and the global health status/QoL scale will be collected and the change from baseline will be summarized at each prespecified time point. | ClinicalTrials.gov |
| Secondary | Organ Preservation Rate | At the time of definitive surgery (after completion of 2 cycles of neoadjuvant therapy). | Organ preservation rate is defined as the proportion of participants who undergo definitive surgery without orbital exenteration or extensive craniofacial/maxillary resection. Organ preservation status will be determined from the surgical record and multidisciplinary team assessment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)