AzTrials
AzTrials

Colorectal Cancer MetastaticPhase 1/2TriComBNCT04564898

Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients.

A Phase 1/2 study testing Capecitabine, Bevacizumab and Trifluridine/Tipiracil in people with Colorectal Cancer Metastatic, run by Gruppo Oncologico del Nord-Ovest at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Metastatic
What is being tested?
Capecitabine, Bevacizumab and Trifluridine/Tipiracil
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesItaly
Study dates
25 Jan 2022to Nov 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent to study procedures.
  • Histologically proven diagnosis of colorectal cancer.
  • Metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
  • At least one measurable lesion according to RECIST1.1.
  • Age ≥ 18 years.
  • ECOG PS ≤ 1.
Show all 18Show fewer
  • Life expectancy of at least 12 weeks.
  • Previous adjuvant fluoropyrimidine-based chemotherapy allowed only if more than 12 months elapsed between the end of adjuvant and first relapse.
  • Availability of archival tumour tissue (primary tumour and metastases or at least one of the two) for biomarker analysis.
  • Availability of blood sample for biomarker analysis.
  • Previously not eligible for a chemotherapy doublet or triplet (oxaliplatin and/or irinotecan-based combination).
  • Neutrophils ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hemoglobin ≥ 9 g/dl.
  • Total bilirubin ≤1.5 fold the upper-normal limits (UNL), AST (SGOT) and/or ALT (SGPT) ≤ 2.5 x UNL (or <5 x UNL in the case of liver metastases), alkaline phosphatase ≤ 2.5 x UNL (or <5 x UNL in case of liver metastases).
  • Creatinine clearance ≥ 50 mL/min or serum creatinine ≤1.5 x UNL.
  • Male subjects with female partners of childbearing potential must be willing to use adequate contraception as approved by the investigator (barrier contraceptive measure or oral contraception).
  • Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.
  • Subjects and their partners must be willing to avoid pregnancy during the trial and until 6 months after the last trial treatment.
  • Will and ability to comply with the protocol.

Who cannot join

  • Radiotherapy to any site within 4 weeks before the study.
  • Previous treatment with trifluridine/tipiracil, bevacizumab and capecitabine (previous treatment with capecitabine was permitted only in the adjuvant setting and if more than 12 months elapsed between the end of adjuvant and first relapse).
  • Untreated brain metastases or spinal cord compression or primary brain tumors.
  • History or evidence upon physical examination of CNS disease unless adequately treated.
  • Clinical signs of malnutrition.
  • Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration.
Show all 18Show fewer
  • Evidence of bleeding diathesis or coagulopathy.
  • Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication.
  • Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
  • Any previous venous thromboembolism ≥ NCI CTCAE Grade 4.
  • History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
  • Treatment with any investigational drug within 30 days prior to enrolment or 2 investigational agent half-lives (whichever is longer).
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
  • Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
  • Known hypersensitivity to trial drugs or hypersensitivity to any other component of the trial drugs.
  • Any concomitant drugs contraindicated for use with the trial drugs according to the product information of the pharmaceutical companies.
  • Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) during the study and until 6 months after the last trial treatment.

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Fondazione IRCCS Istituto Nazionale Tumori

    Milan, MI, 20133

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, PI, 56126

Other trials in Italy

About this study

Official title: A Phase I/II Study Exploring the Safety and Activity of Trifluridine/Tipiracil in Combination With Capecitabine and Bevacizumab in Metastatic Colorectal Cancer Patients

The aim oh this study is to determine the safety and recommended dose of trifluridine/tipiracil plus capecitabine and bevacizumab combination (part 1, dose escalation phase) and to assess its activity in previously untreated mCRC patients who are deemed not eligible for intensive chemotherapy (part 2, expansion phase).

Read the detailed description

This is an open-label, multicenter, phase 1/2 study evaluating the safety and activity of trifluridine/tipiracil in combination with capecitabine and bevacizumab in mCRC. The first part (Part 1) of the study will consist in a dose-escalation assessment of the safety of the treatment in subjects with previously untreated mCRC deemed not fit for irinotecan- and/or oxaliplatin- based regimens (i. e. FOLFOX/XELOX/FOLFIRI/FOLFOXIRI with or without targeted agents).

The second part (Part 2) will be an open-label phase 2 study with a Fleming's single-stage design to evaluate the ORR of the study treatment at the recommended dose established in the first part of the study in the same patients' population.

Trifluridine/tipiracil, capecitabine and bevacizumab will be administered in 28-days cycles until progressive disease, unacceptable toxicities, or patients' refusal.

Being tested
Capecitabine, Bevacizumab, Trifluridine/Tipiracil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CapecitabineDrug

    Part 1 • Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days

    Part 2

    • Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days

  • BevacizumabDrug

    Part 1 • Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days

    Part 2

    • Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days

  • Trifluridine/TipiracilDrug

    Part 1 • Trifluridine/tipiracil, dose escalation from 25 mg/sqm to 35 mg/sqm orally twice daily on days 15-19 (and days 22-26) each 28 days

    Part 2

    • Trifluridine/tipiracil, at the recommanded dose established during part 1 orally twice daily on days 15-19 (and days 22-26) each 28 days
Study groups in NCT04564898
Study groupRoleWhat they receive
trifluridine/tipiracil plus capecitabine and bevacizumabExperimentalNot described
Receives: Drug: Capecitabine; Drug: Bevacizumab; Drug: Trifluridine/Tipiracil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. recommended dose

    recommended dose of the combination trifluridine/tipiracil plus capecitabine plus bevacizumab

    Measured: 2 years

  2. activity

    activity of the combination trifluridine/tipiracil plus capecitabine plus bevacizumab in terms of overaal response rate per RECIST v1.1.

    Measured: 3 years

Secondary outcomes (4)

  1. quality of life for cancer patients

    quality of life as measured by EORTC QLQ-C30 questionnaire.

    Measured: 3 years

  2. quality of life for colorectal cancer patients

    quality of life as measured by EORTC QLQ-CR29 questionnaire.

    Measured: 3 years

  3. quality of life for dimensions health

    quality of life as measured by EuroQol EQ-5D questionnaire.

    Measured: 3 years

  4. survival

    efficacy of the combination trifluridine/tipiracil plus capecitabine plus bevacizumab in terms of progression-free survival and overall survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2020
  2. Study start25 Jan 2022
  3. Primary completion29 May 2024
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04564898
Sponsor's protocol ID
2024-513271-41-00
Acronym
TriComB
Status last verified
May 2026
First submitted
12 Sep 2020
Last updated
20 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Capecitabine, Bevacizumab and Trifluridine/Tipiracil in people with Colorectal Cancer Metastatic, run by Gruppo Oncologico del Nord-Ovest at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

recommended dose (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04564898.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in