Trial · NCT05200650
A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor
NCT05200650, Phase 1, Unknown, IntraGel Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor. Trials, record NCT05200650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05200650
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor
- NCT number
- NCT05200650
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- IntraGel Therapeutics
- Conditions
- Head and Neck Cancer
- Interventions
- TumoCure
- First posted
- 2022-01-21
- Last updated
- 2024-10-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Serious Adverse Events | 90 days | Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days) |
| Secondary | Change in Tumor Size (Efficacy) | 90 days | change in tumor size from baseline to the end of the follow up period (90 days) according to the RECIST methodology, as determined by MRI/CT imaging |
| Other | Overall Survival | 90 days | Overall survival (OS) throughout the follow up period (90 days) |
| Other | Subject Quality of Life | 90 days | Subject Quality of Life (QoL), as determined by the change in EORTC-QLQ30 (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - 30) total score (ranging from 30-120, the lower the result, the better quality of life the subject reports) from baseline to end of follow up period. |
| Other | Subject Quality of Life | 90 days | EORTC-QLQ HNC43 (European Organization for Research and Treatment of Cancer - Quality of Life Head and Neck Questionnaire 43) questionnaire total score (ranging from 43-172, the lower the result the better quality of life the subject reports) from baseline to end of follow up period. |
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/NCT05200650
GET https://conductscience.org/api/trials/v1/NCT05200650/registered