Trial · NCT06553365
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
NCT06553365, Phase 2, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors. Trials, record NCT06553365. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06553365
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors
- NCT number
- NCT06553365
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Conditions
- Nerve Sheath Tumor
- Interventions
- FCN-159
- First posted
- 2024-08-14
- Last updated
- 2025-07-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) estimated by investigators | Every 4 cycles (each cycle is 28 days), assessed up to 2 years | Investigator-assessed objective mitigation rate ORR (Reponse evaluation in Nerufibromatosis and Schwannomatosis, REiNS criteria and RECIST 1.1 criteria, respectively) |
| Secondary | Clinical benefit rate (CBR) estimated by investigators | Every 4 cycles (each cycle is 28 days), assessed up to 2 years | Clinical benefit rate CBR will be assessed by the investigator (REiNS criteria and RECIST 1.1 criteria respectively) |
| Secondary | 24-week word recognition score (WRS) | up to 24 weeks | Hearing response changes will be assessed in patients with hearing impairment (24-week word recognition scores and pure tone audiometry). |
| Secondary | pain estimated by NRS | Every 4 cycles (each cycle is 28 days), assessed up to 2 years | Change in pain intensity score relative to baseline will be assessed according to NRS scale. |
| Secondary | Duration of response (DOR) assessed by investigator | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | Duration of response (DoR) is estimated by the investigators as the time from treatment initiation to disease progression or death in patients who achieve complete or partial response, using both RECIST V1.1 and REINS criteria. |
| Secondary | progression free survival (PFS) assessed by investigator | From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years | PFS is estimated by the investigators as the time from treatment initiation to disease progression or death in patients, using both RECIST V1.1 and REINS criteria. |
| Other | life quality assessed by NFTI-QOL | Every 4 cycles (each cycle is 28 days), assessed up to 2 years | Change in quality of life scores relative to baseline will be assessed by Neurofibromatosis type 2 impact on quality of life (NFTI-QOL) score. The higher score means worse life quality. |
| Other | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE 5.0 | During the intervention | Adverse events during treatment of FCN-159 will be assessed by the investigators accroding to CTCAE 5.0. |
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/NCT06553365
GET https://conductscience.org/api/trials/v1/NCT06553365/registered