The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
Study Details
Study Description
Brief 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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TAS-102 combined with bevacizumab
|
Drug: Tas-102(Suyuan) combined with bevacizumab
Tas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks.
|
Outcome Measures
Primary Outcome Measures
- Progression Free Survival [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
Secondary Outcome Measures
- Overall Survival [3 year]
Time from randomization to death from any cause
- Objective Response Rate [2 year]
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)
- Quality of life score [3 year]
Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years
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Life expectancy of at least 3 months
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Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
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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;
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Patients who can not or can not tolerate combination chemotherapy.
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ECOG performance status was PS ≤2;
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According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
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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.
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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.
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Willing and able to follow research protocols and visit plans.
Exclusion Criteria:
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The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
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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,
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the known presence of brain or pial metastases,
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systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
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clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
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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,
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severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
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clinically significant gastrointestinal bleeding,
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known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
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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;
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patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,
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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,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Second Affiliated Hospital of Shandong First Medical University | Tai'an | Shandong | China | 271000 |
Sponsors and Collaborators
- The Second Affiliated Hospital of Shandong First Medical University
Investigators
- Principal Investigator: Haiyan Liu, The Second Affiliated Hospital of Shandong First Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MT-006