An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)

Phase 2

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Drug: Neoadjuvant Chemotherapy; Drug: TACE protocol

• Registration Number: NCT05340231
• Lead Sponsor: Gang Wu

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 unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-15
• Study First Submitted QC: 2022-04-15
• Last Update Submitted: 2022-04-15
• Study First Posted: 2022-04-22
• Last Update Posted: 2022-04-22
• Study Start: 2022-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan;
2. Aged >=18 years, <= 85 years;
3. Histologically confirmed initial unresectable colorectal cancer;
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
5. Expected survival period ≥ 3 months;
6. At least one measurable lesion, according to RECIST 1.1;
7. The main function is normal.

Exclusion Criteria

1. Known hypersensitivity to any of the study drugs or excipients;
2. Hypertension that is not controlled by the drug;
3. International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;
4. WBC count < 3000 /mm^3;
5. Platlet count < 50000 /mm^3;
6. Poorly controlled diabetes before enrollment;
7. Clinically significant electrolyte abnormalities judged by researchers;
8. Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment;
9. 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%;
10. Active infection or serious infection that is not controlled by drug;
11. History of clinically significant hepatic disease (ALT and/or AST >5 times the upper normal limit);
12. Women who are pregnant or lactating;
13. Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g;
14. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Neoadjuvant Chemotherapy	neoadjuvant chemotherapy alone
Study group	TACE protocol	sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
PFS	up to 3 years	PFS was defined as the time from recruitment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
ORR	up to 3 years	ORR is defined as the percentages of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria
Overall survival (OS)	up to 3 years	The time from recruitment to death due to any cause.
Pathological response rate (PCR+MPR)	up to 3 years	Pathologic complete response (pCR) was defined as absence of viable tumor in the post-treatment surgical specimens and major pathologic response (MPR) was defined as ≤ 10% viable tumor.