Colo-rectal CancerPhase 2NCT07085169
Low-dose Trifluridine/Tipiracil With Bevacizumab in mCRC
A Phase 2 study testing Trifluridine/tipiracil (TAS-102) plus bevacizumab in people with Colo-rectal Cancer and Third-line and Beyond Therapy, run by Ruijin Hospital at 2 sites in China.
Trial summary
This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Colo-rectal Cancer, Third-line and Beyond Therapy, TAS 102
- What is being tested?
- Trifluridine/tipiracil (TAS-102) plus bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 1 Aug 2028
- Phase
- Phase 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 60 years old, male and female
- histologically confirmed adenocarcinoma of the colon or rectum
- patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
- with or without measurable lesions
- ECOG 0 to 2, expected survival time over 3 months
- Enough organ functions that can tolerate treatment: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥80g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
- Signed informed consent and willing to follow the study protocol
Who cannot join
- symptomatic metastases of central nervous system
- other primary malignancies
- uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
- organ functions that cannot tolerate study treatment
- bowel obstruction or other conditions affecting oral administration
- allergic to study medication
- other conditions that patients are unsuitable for this study assessed by the investigators
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
SanMing First Hospital
Sanming
- Recruiting
Ruijin Hospital
Shanghai
About this study
Official title: Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study
This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Read the detailed description
The treatment options as third-line therapy for metastatic colorectal cancer patients are limited. Trifluridine/tipiracil (TAS-102) plus bevacizumab has been approved in colorectal cancer for patients who are refractory to or intolerant of standard chemotherapy. However, the toxicity of trifluridine/tipiracil at standard dose a clinical concerned issue. Modifications of dose and treatment cycle of trifluridine/tipiracil have been investigated, and show promising effect to reduce the toxicity. In this study, patients with refractory metastatic colorectal cancer who have disease progression after at least 2 standard regimens will be treated with low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
- Being tested
- Trifluridine/tipiracil (TAS-102) plus bevacizumab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trifluridine/tipiracil (TAS-102) plus bevacizumabDrug
Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Trifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w Receives: Drug: Trifluridine/tipiracil (TAS-102) plus bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival rate
Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.
Measured: 6 months
Secondary outcomes (4)
Adverse events
Measured: through study completion, an average of 1 year
Objective response rate
Measured: up to 16 weeks
Progression free survival
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Measured: From date of enrollment until the date of death from any cause, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients will receive low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Zhang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085169
- Sponsor's protocol ID
- TAS-102/2025-No.412
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Trifluridine/Tipiracil With Bevacizumab in Refractory Metastatic Colorectal Cancer: a Multicenter, Single-arm, Phase 2 Study
- ClinicalTrials.gov ID
- NCT07085169
- Acronym / sponsor ID
- TAS-102/2025-No.412
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, single-center, prospective trial aimed to investigate the efficacy and safety of a modified regimen of trifluridine/tipiracil plus bevacizumab in refractory metastatic colorectal cancer. Patients will be treated with trifluridine/tipiracil (17.5 mg/m2 dose orally twice daily, d1-10, every 14-days) plus bevacizumab (5mg/kg dose intravenously once at day 1, every 14-days). The study treatment will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Detailed description
The treatment options as third-line therapy for metastatic colorectal cancer patients are limited. Trifluridine/tipiracil (TAS-102) plus bevacizumab has been approved in colorectal cancer for patients who are refractory to or intolerant of standard chemotherapy. However, the toxicity of trifluridine/tipiracil at standard dose a clinical concerned issue. Modifications of dose and treatment cycle of trifluridine/tipiracil have been investigated, and show promising effect to reduce the toxicity. In this study, patients with refractory metastatic colorectal cancer who have disease progression after at least 2 standard regimens will be treated with low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients will receive low-dose trifluridine/tipiracil plus bevacizumab. Trifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Trifluridine/tipiracil (TAS-102) plus bevacizumabTrifluridine/tipiracil 17.5 mg/m2 bid. po. d1-10, q2w Bevacizumab 5mg/kg ivgtt. d1 q2w |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age over 60 years old, male and female
- histologically confirmed adenocarcinoma of the colon or rectum
- patients with metastatic or advanced unresectable diseases who had received two or more previous chemotherapy regimens or intolerance to last regimen
- with or without measurable lesions
- ECOG 0 to 2, expected survival time over 3 months
Key exclusion criteria (7 listed)
- symptomatic metastases of central nervous system
- other primary malignancies
- uncontrollable comorbidities, such as hypertension, thrombotic diseases, chronic kidney disease
- organ functions that cannot tolerate study treatment
- bowel obstruction or other conditions affecting oral administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trifluridine/tipiracil (TAS-102) plus bevacizumabTrifluridine/tipiracil will be given at a 17.5 mg/m2 dose orally twice daily in a 14-day cycle consisting of 10 treatment days/4 rest days. Bevacizumab will be given at a 5mg/kg dose intravenously once at day 1 in a 14-day cycle. This is a single-arm study with all patients receiving these two drugs. | Drug | Experimental |
Primary outcome
6-month progression-free survival rate
Time frame: 6 months
Defined as the proportion of patients who remain free from disease progression (as per RECIST criteria) or death for at least 6 months following initiation of study treatment.
4 secondary outcomes
Adverse events
Time frame: through study completion, an average of 1 year
Objective response rate
Time frame: up to 16 weeks
Progression free survival
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Time frame: From date of enrollment until the date of death from any cause, assessed up to 100 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trifluridine/tipiracil (TAS-102) plus bevacizumab in people with Colo-rectal Cancer and Third-line and Beyond Therapy, run by Ruijin Hospital at 2 sites in China.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Jul 2025. 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 China. 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 phase mean?
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?
Contact Chen-Fei Zhou, MD, Ph.D (+86-21-64370045, zcf12085@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month progression-free survival rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.