Trial · NCT04074343
TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma
NCT04074343, Phase 1, Completed, University of California, Irvine; results first posted 2024-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma. Trials, record NCT04074343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04074343
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS-102 and Irinotecan in 2L+ Gastric and Gastroesophageal Adenocarcinoma
- NCT number
- NCT04074343
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of California, Irvine
- Conditions
- Gastric Adenocarcinoma, GastroEsophageal Cancer
- Interventions
- TAS-102, Irinotecan
- First posted
- 2019-08-30
- Last updated
- 2024-02-02
- Results first posted
- 2024-02-02
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression-free Survival at 6 Months | 6 Months | This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined as death, radiographic progression or clinical deterioration attributed to disease progression as judged by an investigator. Radiographic progression is defined using the Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of diameters of target lesions and an absolute increase of an least 5 mm and/or appearance of new lesions. |
| Secondary | Number of Participants With Grade 3-5 Adverse Events | 8 Weeks | To evaluate the tolerability of administering TAS-102 in combination with Irinotecan in patients with advanced recurrent or unresectable gastric and gastroesophageal adenocarcinoma for the first 2 cycles of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0. |
| Secondary | Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan | From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. | To assess the objective response rate to the combination of TAS-102 and Irinotecan. Objective response rate (ORR) is defined as confirmed complete response (CR) and partial response (PR). Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1): Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. ORR = CR + PR |
| Secondary | Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan | From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first. | To evaluate overall survival in patients with advanced recurrent or unresectable and gastroesophageal adenocarcinoma treated with this combination of TAS-102 and Irinotecan. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression-free Survival at 6 Months | 6 Months | percent of participants | NUMBER | |
| SECONDARY | Number of Participants With Grade 3-5 Adverse Events | 8 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan | From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan | From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression-free Survival at 6 Months | TAS-102 and Irinotecan | 40 | 95% Confidence Interval 19.3 to 60.0 | percent of participants | |
| Number of Participants With Grade 3-5 Adverse Events | TAS-102 and Irinotecan | 8 | Participants | ||
| Objective Response Rate as Assessed by RECIST v1.1 Criteria of Patients Who Received TAS-102 and Irinotecan | TAS-102 and Irinotecan | 0 | Participants | ||
| Overall Survival of Patients of Patients Who Received TAS-102 and Irinotecan | TAS-102 and Irinotecan | 12.2 | 95% Confidence Interval 5.9 to 18.6 | Months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TAS-102 and Irinotecan | 20 | |
| Overall Study | COMPLETED | TAS-102 and Irinotecan | 20 | |
| Overall Study | NOT COMPLETED | TAS-102 and Irinotecan | 0 |
Source ClinicalTrials.gov
Adverse events17
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | General disorders | TAS-102 and Irinotecan | 14 | 20 | |
| other | Diarrhea | Gastrointestinal disorders | TAS-102 and Irinotecan | 10 | 20 | |
| other | Fatigue | General disorders | TAS-102 and Irinotecan | 10 | 20 | |
| other | Abdominal Pain | General disorders | TAS-102 and Irinotecan | 7 | 20 | |
| other | Vomiting | General disorders | TAS-102 and Irinotecan | 6 | 20 | |
| other | Anorexia | Nervous system disorders | TAS-102 and Irinotecan | 6 | 20 | |
| other | Alopecia | Immune system disorders | TAS-102 and Irinotecan | 4 | 20 | |
| other | Constipation | Gastrointestinal disorders | TAS-102 and Irinotecan | 3 | 20 | |
| other | Headache | General disorders | TAS-102 and Irinotecan | 3 | 20 | |
| other | Mucositis oral | General disorders | TAS-102 and Irinotecan | 2 | 20 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS-102 and Irinotecan | 17 | 20 |
| Total, other adverse events | TAS-102 and Irinotecan | 20 | 20 |
| Total, serious adverse events | TAS-102 and Irinotecan | 2 | 20 |
Source ClinicalTrials.gov
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/NCT04074343
GET https://conductscience.org/api/trials/v1/NCT04074343/registered