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Efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib for third-line treatment of unresectable metastatic colorectal cancer.

Phase 4
Conditions
colorectal cancer
Registration Number
ChiCTR2400088929
Lead Sponsor
The First Affiliated Hospital of Wenzhou Medical University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time > 3 months;<br>2.Patients with advanced colorectal adenocarcinoma confirmed by histopathology who had failed standard first - and second-line treatment;<br>3.At least 1 measurable lesion was present according to RECIST1.1 criteria;<br>4.Good organ function, laboratory tests meet the following criteria:<br>1)Hemoglobin =90g/L;Absolute count of neutrophils (ANC) =1.5×109/L;Platelet =100×109/L;<br>2)ALT and AST=2.5 upper limit of normal (ULN).ALP=2.5 ULN;(if liver metastases =5 ULN);<br>3)Total bilirubin (TBIL) < 1.5 ULN;<br>4)Serum creatinine (CR) <1.5 ULN or creatinine clearance (CCR) =50ml/min;<br>5)Serum albumin =30g/L;<br>6)International Normalized ratio (INR), prothrombin time (PT), activated partial thrombin time (APTT) =1.5ULN;<br>7)Thyrotropin (TSH) =ULN;If abnormal, T3 and T4 levels should be investigated, and normal levels can be included;<br>5.cardiac color ultrasound: Left ventricular ejection fraction (LVEF) =50%;<br>6.Hypertension was well controlled;<br>7.Female participants of reproductive age should agree to use contraception during the study period and for 6 months after the study ends; Serum pregnancy test was negative within 7 days prior to study enrollment,and should be Non-lactation stage. Male subjects should agree to use contraception during the study period and for 6 months after the study ends.

Exclusion Criteria

1.Combined disease or history<br>(1).Present or present with other malignancies within 3 years.<br>(2).Have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, or intestinal obstruction)<br>(3).Gastrointestinal bleeding or perforation occurred during the first 4 weeks of enrollment<br>(4).Patients with ulcerative colitis, Crohn's disease, and active inflammatory bowel disease during the first 4 weeks of enrollment<br>(5).Uncontrolled pleural effusion, ascites, and moderate or greater pericardial effusion<br>(6).Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.<br>(7).Received major surgical treatment or significant traumatic injury within 28 days prior to enrollment<br>(8).Patients with hematemesis, hematochezia, or any bleeding event = CTCS AE level 3 within the previous 3 months, or with any signs of bleeding or history determined by the investigator to be ineligible for enrollment<br>(9).Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident, pulmonary embolism, etc<br>(10).A history of psychotropic substance abuse and inability to abstain<br>(11).Subjects with any severe and/or uncontrolled disease, including<br>1)Uncontrolled hypertension<br>2)Unstable angina pectoris / = grade 2 cardiogenic chest pain;Myocardial infarction occurred within 12 months before randomization;= grade 2 heart failure;Restrictive heart disease;= grade 2 atrioventricular block, arrhythmia that cannot be stably controlled with drugs.<br>3)Active infection<br>4)Decompensated cirrhosis, active hepatitis;<br>5)Renal failure requires hemodialysis or peritoneal dialysis<br>6)A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation<br>7)Diabetes with poorly controlled<br>8)Urine routine showed urine protein =++, and 24h albuminuria quantitative > 1.0 g<br>9)History of neurological or psychiatric disorders<br>2.Subjects who, in the investigator's judgment, have a concomitant medical condition that seriously endangers subjects' safety or interferes with the completion of the study, or are deemed unsuitable for enrollment for other reasons.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Progression-free survival;
Secondary Outcome Measures
NameTimeMethod
Total survival time;Objective Response Rate;Quality of life;
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