Colorectal CancerPhase 2NCT06092242
The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
A Phase 2 study testing Tas-102(Suyuan) combined with bevacizumab in people with Colorectal Cancer, run by The Second Affiliated Hospital of Shandong First Medical University at 1 site in China.
Trial summary
To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Tas-102(Suyuan) combined with bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 15 Oct 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Life expectancy of at least 3 months
- Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
- Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
- Patients who can not or can not tolerate combination chemotherapy.
- ECOG performance status was PS ≤2;
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- According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
- Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle 1.
- A .The hemoglobin value was more than 90 g/L. B. The absolute neutrophil count was > 1.500 MM3. C. Platelet count was > GT; 100,000/mm (> GT; 100 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 ml/min;.
- G.Adequate coagulation: international standard ratio (INR) or prothrombin time (PT)≤1.5 times the upper limit of normal;. Urine or serum pregnancy tests were negative within 7 days of randomization.
- Women at risk of pregnancy must agree to use adequate contraception during the study until 6 months after the cessation of the study drug; Men had to agree to use adequate contraception during the study until six months after the study drug was discontinued.
- Willing and able to follow research protocols and visit plans.
Who cannot join
- 1. The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
- the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
- the known presence of brain or pial metastases,
- systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
- clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
- uncontrolled diabetes;
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- patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,
- severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
- clinically significant gastrointestinal bleeding,
- known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
- presence of psychiatric disorders that may increase the risk of participating in the study or taking research drugs, or that may interfere with the interpretation of the study results;
- patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,
- patients with nephrotic syndrome or with proteinuria ≥2 + or more before treatment who had not improved or were unstable after treatment, 13-RRB- patients with a history of gastrointestinal perforation in the last 6 months,
- patients with Hypertensive crisis hypertensive encephalopathy. 2.Any of the following treatments were performed within a specific time frame prior to study drug administration,
- 1）major surgery (laparotomy, thoracotomy, and evisceration by laparoscopy) was performed within the previous 4 weeks. Switch surgery was not included) ; 2) had received extended-range radiotherapy within the previous 4 weeks or had received limited-range radiotherapy within the previous 2 weeks; 3) had received any investigational medication within the previous 4 weeks. 3. Neurotoxicity of CTCAE grade 2 or above that has not subsided as a result of adjuvant therapy, 4. A pregnant or lactating woman. 5. The researchers did not consider it appropriate to enter 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
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, 271000
About this study
To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy
- Conditions
- Colorectal Cancer
- Being tested
- Tas-102(Suyuan) combined with bevacizumab
- Keywords
- Colorectal Cancer
- 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(Suyuan) combined with bevacizumabDrug
Tas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks.
| Study group | Role | What they receive |
|---|---|---|
| TAS-102 combined with bevacizumab | Experimental | Not described Receives: Drug: Tas-102(Suyuan) combined with bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
Measured: 2 years
Secondary outcomes (3)
Overall Survival
Time from randomization to death from any cause
Measured: 3 year
Objective Response Rate
It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)
Measured: 2 year
Quality of life score
Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyan Liu, Principal investigator, The Second Affiliated Hospital of Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092242
- Sponsor's protocol ID
- MT-006
- Status last verified
- Oct 2023
- First submitted
- 14 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06092242
- Acronym / sponsor ID
- MT-006
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Shandong First Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 23 Oct 2023 (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.
To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAS-102 combined with bevacizumab | Experimental | Drug: Tas-102(Suyuan) combined with bevacizumab |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥18 years
- Life expectancy of at least 3 months
- Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
- Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
- Patients who can not or can not tolerate combination chemotherapy.
Key exclusion criteria (15 listed)
- 1. The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
- the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
- the known presence of brain or pial metastases,
- systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
- clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
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(Suyuan) combined with bevacizumabTas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks. | Drug | TAS-102 combined with bevacizumab |
Primary outcome
Progression Free Survival
Time frame: 2 years
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse
3 secondary outcomes
Overall Survival
Time frame: 3 year
Objective Response Rate
Time frame: 2 year
Quality of life score
Time frame: 3 year
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 23 Oct 2023.
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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.
Haiyan Liu principal investigator
The Second Affiliated Hospital of Shandong First Medical University
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(Suyuan) combined with bevacizumab in people with Colorectal Cancer, run by The Second Affiliated Hospital of Shandong First Medical 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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 23 Oct 2023. 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 Ying Kong (13153882807, kongyingcoco@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 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 23 Oct 2023.