Trial · NCT06772233
A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment
NCT06772233, Phase 2, Not yet recruiting, Peking University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment. Trials, record NCT06772233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06772233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Regorafenib Combined With Envafolimab for Metastatic Gastrointestinal Stromal Tumors With Kit Gene Exon 17 Mutation That Failed Standard Treatment
- NCT number
- NCT06772233
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Peking University
- Conditions
- Metastatic Gastrointestinal Stromal Tumors (GIST)
- Interventions
- regorafenib combined with envafolimab, Control Group
- First posted
- 2025-01-13
- Last updated
- 2025-07-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From enrollment to disease progression or death, whichever came first, assessed up to 2 years | Assessed by the investigator according to mRECIST 1.1 criteria |
| Secondary | Overall Survival (OS) | Overall Survival (OS): from enrollment to death, assessed up to 2 years | Overall Survival (OS): Assessed by the investigator according to mRECIST 1.1 criteria. |
| Secondary | Objective Response Rate (ORR) | assessed up to 2 years | Objective Response Rate (ORR): Assessed by the investigator according to mRECIST 1.1 criteria. |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | assessed up to 2 years | The safety parameters of this study include clinical symptoms, vital signs, physical examinations, and laboratory tests (routine, urinalysis, blood biochemistry, thyroid function, coagulation function, etc.). Adverse events (AEs) observed will be evaluated according to version 5.0 of the NCI-CTCAE, including type, incidence, severity, onset and end times, whether they are serious adverse events, and their relationship to the study drug. The assessment of postoperative complications includes type, incidence, and grading (based on the Clavien-Dindo classification system). |
| Other | Exploratory Study Endpoints-Correlation between the immune microenvironment of GIST and the efficacy of immunotherapy. | From enrollment to the end of the study, assessed up to 2 years | Before enrollment, provide 15 paraffin tissue sections for the detection of immune microenvironment-related indicators, including PD-L1, CD4+ T cells, CD8+ T cells, and tumor-infiltrating lymphocytes (TILs). |
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/NCT06772233
GET https://conductscience.org/api/trials/v1/NCT06772233/registered