Trial · NCT05482516
Evaluating Novel Therapies in ctDNA Positive GI Cancers
NCT05482516, Phase 3, Active not recruiting, Georgetown University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluating Novel Therapies in ctDNA Positive GI Cancers. Trials, record NCT05482516. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05482516
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluating Novel Therapies in ctDNA Positive GI Cancers
- NCT number
- NCT05482516
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 11 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Colon Adenocarcinoma, Rectal Adenocarcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma, Hepatocellular Carcinoma, Adenocarcinoma of Biliary Tract, Gallbladder Adenocarcinoma
- Interventions
- Atezolizumab, Bevacizumab
- First posted
- 2022-08-01
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rates of SignateraTM ctDNA positive Patient identification | 12 months | The number of local and regional SignateraTM ctDNA positive patients identified over 12 months in the setting of NED after all SOC definitive therapies (identified patients). This data will be obtained on a local and regional level through the SignateraTM company, Natera. |
| Primary | Rate of Enrollment | 12 months | Percentage and absolute number of contacted patients who ultimately enrolled on trial (enrolled patients) |
| Primary | Rate of ctDNA Complete Response (CR) | 12 weeks from start of treatment | Percentage of patients in each cohort (and collectively) who achieve ctDNA CR (defined as ctDNA clearance on two sequential tests compared to baseline ctDNA and ongoing NED clinically/radiographically) within 12 weeks ± 14 days of study therapy. |
| Primary | Rate of ctDNA Partial Response (PR) | 12 weeks from start of treatment | Percentage of patients in each cohort (and collectively) who achieve ctDNA PR (ctDNA does not clear on two sequential tests, ctDNA does not double on each of two consecutive tests, does not increase on each of three consecutive tests, and ongoing NED clinically/radiographically) within 12 weeks ± 14 days of study therapy. |
| Primary | Rate of ctDNA Progression of Disease (POD) or Clinical/radiographic Relapse | 12 weeks from start of treatment | Rate of ctDNA POD or clinical/radiographic relapse is defined as the percentage of patients in each cohort (and collectively) who experience ctDNA doubling (at least) on each of two consecutive, sequential tests using the prior ctDNA value as the reference point for doubling for each test, ctDNA rise on each of three consecutive ctDNA tests using the prior ctDNA value as the reference point for each test (ctDNA POD), or clinical/radiographic relapse within 12 weeks ± 14 days of study therapy. |
| Secondary | Toxicity by CTCAE v5.0 criteria | 12 months | Toxicity and safety analysis will occur in patients who received at least one full or partial dose of study treatment. Adverse events will be graded per NCI CTCAE v.5.0. |
| Secondary | Reasons for failure of enrollment | 12 months | Reasons for failure of enrollment characterized as patient preference, physician preference, or ineligibility, among others of identified and contacted patients will be reported |
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/NCT05482516
GET https://conductscience.org/api/trials/v1/NCT05482516/registered