Trial · NCT04109924
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
NCT04109924, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2026-02-10
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study. Trials, record NCT04109924. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04109924
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
- NCT number
- NCT04109924
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Roswell Park Cancer Institute
- Conditions
Advanced Colorectal Carcinoma, Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Recurrent Colon Adenocarcinoma, Recurrent Colorectal Adenocarcinoma, Recurrent Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Rectal Cancer AJCC v8, Stage IIIA Colon Cancer AJCC v8, Stage IIIA Colorectal Cancer AJCC v8, Stage IIIB Colorectal Cancer AJCC v8, Stage IIIB Rectal Cancer AJCC v8, Stage IIIC Colon Cancer AJCC v8, Stage IIIC Colorectal Cancer AJCC v8, Stage IV Colon Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Rectal Cancer AJCC v8, Stage IVB Colon Cancer AJCC v8, Stage IVB Colorectal Cancer AJCC v8, Stage IVB Rectal Cancer AJCC v8, Stage IVC Colon Cancer AJCC v8, Stage IVC Colorectal Cancer AJCC v8, Stage IVC Rectal Cancer AJCC v8, Unresectable Colon Adenocarcinoma, Unresectable Colorectal Carcinoma, Unresectable Rectal Adenocarcinoma
- Interventions
- Irinotecan, Bevacizumab, Trifluridine and Tipiracil Hydrochloride
- First posted
- 2019-10-01
- Last updated
- 2026-02-10
- Results first posted
- 2026-02-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | Will be assessed via the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 guidelines. The PFS will be summarized using standard Kaplan-Meier methods, where estimates of the median PFS and 6/12-month PFS rates will be obtained with 90% confidence intervals. |
| Secondary | Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | Patients receive irinotecan IV over 90 minutes and bevacizumab IV over 10 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride PO BID on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Irinotecan: Given IV Bevacizumab: Given IV Trifluridine and Tipiracil Hydrochloride: Given PO |
| Secondary | Median Overall Survival (OS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | OS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival are obtained with 90% confidence intervals |
| Secondary | Disease-specific Survival (DSS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | DSS will be summarized using standard Kaplan-Meier methods; where estimates of the median survival and 12-month rates are obtained with 90% confidence intervals. |
| Secondary | Aggregate Rates of Adverse Events | Follow-up safety evaluations will occur 30 days (± 3 days) after last dose of study drug or until resolution of any drug related toxicity (telephone contact is acceptable), through study completion , an average of 3.5 years work | measured by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and recorded to objectively measure toxicities of the combination therapy. Treatment related adverse events (as per CTCAE v5.0) will be summarized by grade using frequencies and relative frequencies. Only grade 4 and 5 adverse events are reported here. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival (PFS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | Only 35 patients completed treatment. The primary outcome(i.e. Median progression free survival (PFS)) analysis is based on these 35 patients who completed treatment. | months | MEDIAN |
| SECONDARY | Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | Only 35 patients completed treatment. The primary outcome(i.e. Median progression free survival (PFS)) analysis is based on these 35 patients who completed treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Overall Survival (OS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | months | MEDIAN | |
| SECONDARY | Disease-specific Survival (DSS) | Medical record review will be performed approximately every 6 months, for up to 2 years, post treatment up to 4 years | months | MEDIAN | |
| SECONDARY | Aggregate Rates of Adverse Events | Follow-up safety evaluations will occur 30 days (± 3 days) after last dose of study drug or until resolution of any drug related toxicity (telephone contact is acceptable), through study completion , an average of 3.5 years work | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression Free Survival (PFS) | Treatment (Irinotecan, Bevacizumab, TAS-102) | 7.9 | Full Range 5.6 to 11.4 | months | |
| Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Treatment (Irinotecan, Bevacizumab, TAS-102) | CR | 1 | Participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Treatment (Irinotecan, Bevacizumab, TAS-102) | PR | 6 | Participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Treatment (Irinotecan, Bevacizumab, TAS-102) | SD | 20 | Participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease and Progressive Disease | Treatment (Irinotecan, Bevacizumab, TAS-102) | PD | 8 | Participants | |
| Median Overall Survival (OS) | Treatment (Irinotecan, Bevacizumab, TAS-102) | 16.7 | Full Range 11.8 to 22.8 | months | |
| Disease-specific Survival (DSS) | Treatment (Irinotecan, Bevacizumab, TAS-102) | 16.7 | Full Range 11.8 to 22.8 | months | |
| Aggregate Rates of Adverse Events | Treatment (Irinotecan, Bevacizumab, TAS-102) | developed grade 4/5 adverse events | 9 | Participants | |
| Aggregate Rates of Adverse Events | Treatment (Irinotecan, Bevacizumab, TAS-102) | Not developed 4/5 adverse events | 33 | 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 | Treatment (Irinotecan, Bevacizumab, TAS-102) | 42 | |
| Overall Study | COMPLETED | Treatment (Irinotecan, Bevacizumab, TAS-102) | 35 | |
| Overall Study | NOT COMPLETED | Treatment (Irinotecan, Bevacizumab, TAS-102) | 7 |
Source ClinicalTrials.gov
Adverse events80
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 | Anemia | Blood and lymphatic system disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 14 | 42 | 14 |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Sinus tachycardia | Cardiac disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Watering eyes | Eye disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 5 | 42 | 5 |
| other | Anal pain | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Colitis | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Constipation | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 7 | 42 | 7 |
| other | Dental caries | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 1 | 42 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Treatment (Irinotecan, Bevacizumab, TAS-102) | 30 | 42 | 30 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Irinotecan, Bevacizumab, TAS-102) | 33 | 42 |
| Total, other adverse events | Treatment (Irinotecan, Bevacizumab, TAS-102) | 42 | 42 |
| Total, serious adverse events | Treatment (Irinotecan, Bevacizumab, TAS-102) | 12 | 42 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39244627 | DERIVED |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016056 | Roswell Park Cancer Center Support Grant | JOHNSON, CANDACE S | ROSWELL PARK CANCER INSTITUTE CORP | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT04109924
GET https://conductscience.org/api/trials/v1/NCT04109924/events?page=2