Trial · NCT05366816
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
NCT05366816, Phase 2, Recruiting, University of Miami
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST. Trials, record NCT05366816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05366816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
- NCT number
- NCT05366816
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 48 participants, estimated
- Lead sponsor
- University of Miami
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Sunitinib, Regorafenib
- First posted
- 2022-05-09
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Overall Response | Up to 12 months | The overall response rate (ORR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR) or partial response (PR). ORR will be assessed using Choi criteria by treating physician. |
| Secondary | Progression-Free Survival (PFS) | Up to 3 years | Progression-free survival (PFS) will be defined as the time elapsed from the start of treatment to the date of documented progression or death, whichever comes first. For surviving patients without progression who begin alternative treatment, PFS will be censored at the last date of documented progression-free status prior to starting alternative treatment. Similarly, losses to follow up will be censored at the last date of documented progression-free status. |
| Secondary | Overall Survival (OS) | Up to 3 years | Overall survival (OS) will be defined as the time elapsed from the start of treatment until death. For surviving patients, follow-up will be censored at the date of last contact. |
| Secondary | Number of Participants Achieving Clinical Benefit | Up to 12 months | The clinical benefit rate (CBR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR), or partial response (PR), or stable disease (SD), for 6 months or more and will be assessed using Choi criteria by treating physician. |
| Secondary | Incidence of Treatment-Related Toxicity and Adverse Events | Up to 13 months | Safety and tolerability of assigned Sunitinib and Regorafenib treatment will be reported as the incidence of treatment-related toxicity, including serious adverse events (SAEs) and adverse events (AEs), in study participants using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, per physician discretion. |
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/NCT05366816
GET https://conductscience.org/api/trials/v1/NCT05366816/registered