Metastatic Colorectal Cancer (CRC)Phase 2TASBELNCT06856187
Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
A Phase 2 study testing TAS-102+bevacizumab+local treatment and Standard chemotherapy in people with Metastatic Colorectal Cancer (CRC), run by Fudan University at 1 site in China.
Trial summary
This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer (CRC)
- What is being tested?
- TAS-102+bevacizumab+local treatment and Standard chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 30 Apr 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;
- At least one measurable lesion according to RECIST 1.1 criteria;
- ECOG Performance Status 0-1;
- Estimated life expectancy ≥3months;
- Adequate major organ function;
- Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance.
Who cannot join
- Allergy to the investigational drug and/or its excipients;
- Pregnant or lactating women;
- Prior treatment with TAS-102;
- Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
- Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
- Serious illness, including but not limited to the following:
Show all 19Show fewer
- Patients with other malignant tumors within 5 years before enrollment, except basal cell carcinoma of the skin or carcinoma in situ of the cervix;
- Known brain and/or leptomeningeal metastases;
- Active infection or fever of unknown origin > 38.5 ° C ;
- Poorly controlled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) with a previous history of hypertensive crisis or hypertensive encephalopathy;
- Known inherited or acquired bleeding (e.g., coagulopathy)
- Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc., occurred within 6 months before the initiation of study treatment;
- Severe, unhealed or dehiscence wounds and active ulcers or untreated fractures;
- Myocardial infarction, severe/unstable angina, symptomatic congestive heart failure (NYHA Class III or IV) within the last 12 months;
- Acute or subacute intestinal obstruction, or chronic inflammatory bowel disease;
- There are serious psychological or psychiatric abnormalities that affect the compliance of patients to participate in this clinical study.
- Has undergone major surgical treatment (excluding diagnosis) within 4 weeks before the start of the study or is expected to undergo major surgical treatment during the study period;
- Inability to swallow pills, presence of malabsorption syndrome or any condition affecting gastrointestinal absorption;
- The investigator assessed that it is not appropriate to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jinjia Chang, PhD, 86+18017317729
About this study
Official title: A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
Read the detailed description
This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
In this study, 119 metastatic colorectal cancer patients who reach CR/PR/SD after 3 months second-line treatment will be randomized to receive sequential TAS-102 +bevacizumab combined with local treatment or continuous treatment of previous second-line therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, PFS, OS, safety and patient reported outcomes.
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Being tested
- TAS-102+bevacizumab+local treatment, Standard chemotherapy
- Keywords
- Colorectal cancer, TAS-102, second-line therapy, maintainance therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102+bevacizumab+local treatmentDrug
patients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment
Standard chemotherapyDrug
Standard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab
| Study group | Role | What they receive |
|---|---|---|
| Second-line standard therapy sequential TAS-102 and bevacizumab group | Experimental | Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment |
| Continuous therapy of Standard Treatment Group | Active comparator | Continuous therapy of standard treatment regimen Receives: Drug: Standard chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to treatment failure (TTF)
TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
Measured: up to approximately 2 years.
Secondary outcomes (7)
Objective response rate (ORR)
ORR is defined as the percentage of subjects with complete response (CR) or partial response (PR) by investigator assessment per RECIST criteria, version 1.1.
Measured: up to approximately 2 years.
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD).
Measured: up to approximately 2 years.
Progression-free survival (PFS)
PFS is defined as the time from randomization until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Measured: up to approximately 2 years.
Overall survival（OS）
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: up to approximately 2 years.
Adverse Events
AE assessed by NCI-CTCAE v5.0.
Measured: up to approximately 2 years.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
To compare change in Quality of Life, as defined by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30 (Version 3)) during study treatment.
The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.
The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. More points are considered to have a better outcome.
Measured: up to approximately 2 years.
Progression-free survival(PFS2)
PFS2 is defined as the time from receiving second-line standard therapy until the date of first occurrence of investigator-assessed radiological disease progression or death due to any cause, whichever came first.
Measured: up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start28 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Wenhua, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856187
- Sponsor's protocol ID
- FudanU.2411307-13
- Acronym
- TASBEL
- Status last verified
- Aug 2025
- First submitted
- 26 Feb 2025
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase II Clinical Study of Second-line Standard Treatment Sequential TAS-102 and Bevacizumab Combined With Local Treatment in Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06856187
- Acronym / sponsor ID
- TASBEL / FudanU.2411307-13
- Conditions
- Metastatic Colorectal Cancer (CRC)
- Keywords
- Colorectal cancer, TAS-102, second-line therapy, maintainance therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 4 Mar 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 study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
Detailed description
This study is a randomized, controlled, open-label, phase II clinical study. This study is designed to evaluate the efficacy and safety of second-line standard treatment sequential TAS-102 and bevacizumab combined with local treatment versus continuous treatment of standard second-line therapy in advanced colorectal cancer.
In this study, 119 metastatic colorectal cancer patients who reach CR/PR/SD after 3 months second-line treatment will be randomized to receive sequential TAS-102 +bevacizumab combined with local treatment or continuous treatment of previous second-line therapy. The primary endpoint is investigator-assessed time to treatment failure (TTF). Secondary endpoints include ORR, DCR, PFS, OS, safety and patient reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second-line standard therapy sequential TAS-102 and bevacizumab group | Experimental | –Second-line induce therapy followed by TAS-102+bevacizumab maintainance therapy combined with local treatment |
| Continuous therapy of Standard Treatment Group | Active comparator | Drug: Standard chemotherapyContinuous therapy of standard treatment regimen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Unresectable colorectal adenocarcinoma confirmed by histopathology or cytology;
- Patients who have failed first-line standard therapy and are intended to receive second-line standard therapy;
- At least one measurable lesion according to RECIST 1.1 criteria;
- ECOG Performance Status 0-1;
- Estimated life expectancy ≥3months;
Key exclusion criteria (19 listed)
- Allergy to the investigational drug and/or its excipients;
- Pregnant or lactating women;
- Prior treatment with TAS-102;
- Any CTCAE grade 2 or above toxicity caused by previous treatment that has not yet subsided (excluding alopecia, skin pigmentation, and chemotherapy-induced neurotoxicity);
- Known inherited or acquired bleeding (e.g., coagulopathy) or thrombophilia, as in patients with hemophilia; Current or recent (within 10 days before initiation of study treatment) use of a full-dose oral or injectable anticoagulant or thrombolytic agent for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);
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 |
|---|---|---|
| TAS-102+bevacizumab+local treatmentpatients achieve disease control after second-line induction therapy with standard therapy(FOLFOX/FOLFIRI/XELOX/ mXELIRI＋bevacizumab/cetuximab), then achieve TAS-102+bevacizumab+local treatment | Drug | – |
| Standard chemotherapyStandard therapy：FOLFOX/FOLFIRI/XELOX/ mXELIRI±bevacizumab/cetuximab | Drug | Continuous therapy of Standard Treatment Group |
Primary outcome
Time to treatment failure (TTF)
Time frame: up to approximately 2 years.
TTF is defined as the time from the date of randomization to the date of the discontinuation of the trial protocol.
7 secondary outcomes
Objective response rate (ORR)
Time frame: up to approximately 2 years.
Disease control rate (DCR)
Time frame: up to approximately 2 years.
Progression-free survival (PFS)
Time frame: up to approximately 2 years.
Overall survival（OS）
Time frame: up to approximately 2 years.
Adverse Events
Time frame: up to approximately 2 years.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30)
Time frame: up to approximately 2 years.
Progression-free survival(PFS2)
Time frame: up to approximately 2 years.
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 6 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Metastatic Colorectal Cancer (CRC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Metastatic Colorectal Cancer
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Not yet recruitingPhase 1/2
A Phase Ib/II Study of GFH276 in Combination With Chemotherapy (± Bevacizumab) or Cetuximab in Patients With RAS-mutant Metastatic Colorectal Cancer
CRC
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-102+bevacizumab+local treatment and Standard chemotherapy in people with Metastatic Colorectal Cancer (CRC), run by Fudan University at 1 site 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 19 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 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Wenhua Li, Ph.D (8618017317210, whliiris@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to treatment failure (TTF) (time frame: up to approximately 2 years.). 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 6 Aug 2025.