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Trial Title:
The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer
NCT ID:
NCT06092242
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Bevacizumab
Conditions: Keywords:
Colorectal Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tas-102(Suyuan) combined with bevacizumab
Description:
Tas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg,
D1, D15, Q4 wks.
Arm group label:
TAS-102 combined with bevacizumab
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Life expectancy of at least 3 months
3. Definitive histological or cytological evidence of adenocarcinoma of the colon or
rectum;
4. 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;
5. Patients who can not or can not tolerate combination chemotherapy.
6. ECOG performance status was PS ≤2;
7. According to RECIST Version 1.1, at least 1 measurable metastatic lesion was
present;
8. 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.
9. 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.
10. Willing and able to follow research protocols and visit plans.
Exclusion Criteria:
1. The existence of serious diseases and serious medical conditions, this includes, but
is not limited to, the following:
1. 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,
2. the known presence of brain or pial metastases,
3. systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
4. clinically significant intestinal obstruction, pulmonary fibrosis, renal failure,
liver failure, or symptomatic cerebrovascular disease,
5. uncontrolled diabetes;
6. 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,
7. severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
8. clinically significant gastrointestinal bleeding,
9. known presence of human immunodeficiency virus (HIV) or acquired conventional
immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
10. 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;
11. patients with grade 2 or more hypertension before treatment who had not improved or
were unstable with antihypertensive drugs,
12. 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,
13. 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of Shandong First Medical University
Address:
City:
Tai'an
Zip:
271000
Country:
China
Start date:
October 15, 2023
Completion date:
October 15, 2027
Lead sponsor:
Agency:
The Second Affiliated Hospital of Shandong First Medical University
Agency class:
Other
Source:
The Second Affiliated Hospital of Shandong First Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092242
