Status:
UNKNOWN
An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)
Lead Sponsor:
Gang Wu
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unres...
Eligibility Criteria
Inclusion
- Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
- Aged \>=18 years, \<= 85 years;
- Histologically confirmed initial unresectable colorectal cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Expected survival period ≥ 3 months;
- At least one measurable lesion, according to RECIST 1.1;
- The main function is normal.
Exclusion
- Known hypersensitivity to any of the study drugs or excipients;
- Hypertension that is not controlled by the drug;
- International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
- WBC count \< 3000 /mm\^3;
- Platlet count \< 50000 /mm\^3;
- Poorly controlled diabetes before enrollment;
- Clinically significant electrolyte abnormalities judged by researchers;
- Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
- Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%;
- Active infection or serious infection that is not controlled by drug;
- History of clinically significant hepatic disease (ALT and/or AST \>5 times the upper normal limit);
- Women who are pregnant or lactating;
- Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
- Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05340231
Start Date
May 1 2022
End Date
December 31 2025
Last Update
April 22 2022
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