Trial · NCT03686488
TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
NCT03686488, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2023-03-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma. Trials, record NCT03686488. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03686488
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
- NCT number
- NCT03686488
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Gastric Cancer
- Interventions
- TAS 102, Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]
- First posted
- 2018-09-27
- Last updated
- 2026-03-02
- Results first posted
- 2023-03-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | 6 months | Overall survival defined as the time from starting on trial to date of death from any cause. |
| Secondary | Number of Participants With at Least One Adverse Event | 4 weeks after end of study participation, an average of 6.5 months | Number of participants with at least one adverse event. |
| Secondary | Progression Free Survival (PFS) | 6 months | PFS, defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.) |
| Secondary | Objective Response Rate | up to 12 months | Objective Response Rate is defined as complete response (CR) + partial response (PR) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Complete Response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. |
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 | Overall Survival | 6 months | months | MEDIAN | |
| SECONDARY | Number of Participants With at Least One Adverse Event | 4 weeks after end of study participation, an average of 6.5 months | participants | NUMBER | |
| SECONDARY | Progression Free Survival (PFS) | 6 months | months | MEDIAN | |
| SECONDARY | Objective Response Rate | up to 12 months | Evaluable participants | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Overall Survival | TAS 102 and Ramucirumab | 4.8 | 95% Confidence Interval 4.0 to NA | months | |
| Number of Participants With at Least One Adverse Event | TAS 102 and Ramucirumab | 23 | participants | ||
| Progression Free Survival (PFS) | TAS 102 and Ramucirumab | 4.9 | 95% Confidence Interval 4.0 to NA | months | |
| Objective Response Rate | TAS 102 and Ramucirumab | 11 | 95% Confidence Interval 9.622 to 12.578 | percentage of participants |
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 Ramucirumab | 23 | |
| Overall Study | COMPLETED | TAS 102 and Ramucirumab | 23 | |
| Overall Study | NOT COMPLETED | TAS 102 and Ramucirumab | 0 |
Source ClinicalTrials.gov
Adverse events96
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 | Diarrhea | Gastrointestinal disorders | TAS 102 and Ramucirumab | 13 | 23 | 15 |
| other | Nausea | Gastrointestinal disorders | TAS 102 and Ramucirumab | 13 | 23 | 15 |
| other | Vomiting | Gastrointestinal disorders | TAS 102 and Ramucirumab | 12 | 23 | 15 |
| other | Constipation | Gastrointestinal disorders | TAS 102 and Ramucirumab | 6 | 23 | 6 |
| other | Gastrointestinal disorders -Other | Gastrointestinal disorders | TAS 102 and Ramucirumab | 5 | 23 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | TAS 102 and Ramucirumab | 4 | 23 | 9 |
| other | Toothache | Gastrointestinal disorders | TAS 102 and Ramucirumab | 3 | 23 | 3 |
| other | Ascites | Gastrointestinal disorders | TAS 102 and Ramucirumab | 2 | 23 | 2 |
| other | Dysphagia | Gastrointestinal disorders | TAS 102 and Ramucirumab | 2 | 23 | 2 |
| other | Dental caries | Gastrointestinal disorders | TAS 102 and Ramucirumab | 1 | 23 | 2 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TAS 102 and Ramucirumab | 20 | 23 |
| Total, other adverse events | TAS 102 and Ramucirumab | 23 | 23 |
| Total, serious adverse events | TAS 102 and Ramucirumab | 7 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41335458 | DERIVED |
Source PubMed
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/NCT03686488
GET https://conductscience.org/api/trials/v1/NCT03686488/events?page=2