Trial · NCT03368963
TAS102 in Combination With NAL-IRI in Advanced GI Cancers
NCT03368963, Phase 1, Phase 2, Active not recruiting, Emory University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TAS102 in Combination With NAL-IRI in Advanced GI Cancers. Trials, record NCT03368963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03368963
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS102 in Combination With NAL-IRI in Advanced GI Cancers
- NCT number
- NCT03368963
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 64 participants, estimated
- Lead sponsor
- Emory University
- Conditions
Colorectal Adenocarcinoma, Gastric Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma, Non-Resectable Cholangiocarcinoma, Stage IV Colorectal Cancer, Stage IV Gastric Cancer, Stage IV Pancreatic Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer, Stage III Colorectal Cancer, Stage III Gastric Cancer, Stage III Pancreatic Cancer, Unresectable Digestive System Adenocarcinoma, Unresectable Pancreatic Carcinoma
- Interventions
- Nanoliposomal Irinotecan, Trifluridine and Tipiracil Hydrochloride
- First posted
- 2017-12-11
- Last updated
- 2025-01-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events of trifluridine/tipiracil hydrochloride combination agent TAS-102 in combination with nanoliposomal irinotecan | Up to 3 years after end of treatment | Assessed using Common Terminology Criteria for Adverse Events version 4.0. |
| Primary | Overall response rate based on modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Up to 3 years after end of treatment | Defined as the proportion of patients who achieved a complete response (complete response: disappearance of all target tumors) or a partial response (partial response: ≥ 30% decrease in the sum of the longest diameters of target tumors). |
| Secondary | Progression free survival | Up to 3 years after end of treatment | Will be evaluated. |
| Secondary | Response duration | From initial response until documented tumor progression, assessed up to 3 years | Will be estimated by Kaplan-Meier method. P values will be two-sided with significance level of .05. |
| Secondary | Response rate | Up to 3 years after end of treatment | Response assessment will be done according to RECIST 1.1 criteria. A repeat imaging scan of the same modality and technique will be repeated after 4 weeks for confirmation of response. |
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/NCT03368963
GET https://conductscience.org/api/trials/v1/NCT03368963/registered