Status:
NOT_YET_RECRUITING
The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
Lead Sponsor:
The Second Affiliated Hospital of Shandong First Medical University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 chemothera...
Eligibility Criteria
Inclusion
- 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;
- 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.
- F. 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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06092242
Start Date
October 15 2023
End Date
October 15 2027
Last Update
October 23 2023
Active Locations (1)
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1
The Second Affiliated Hospital of Shandong First Medical University
Tai’an, Shandong, China, 271000