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

NCT05340231 | Unknown Phase 2

• 1 other identifier: CRC-2022-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

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

  up to 3 years

Secondary Outcomes (3)

• ORR

  up to 3 years

• Overall survival (OS)

  up to 3 years

• Pathological response rate (PCR+MPR)

  up to 3 years

Study Arms (2)

Study group

EXPERIMENTAL

sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy

Drug: TACE protocol

Control group

ACTIVE COMPARATOR

neoadjuvant chemotherapy alone

Drug: Neoadjuvant Chemotherapy

Interventions

TACE protocol DRUG

Transarterial infusion chemotherapy: Oxaliplatin(85mg/m\^2)+Raltitrexed(3mg) Chemoembolization: Lipiodol emulsion (lipiodol 10ml+ Oxaliplatin 85mg +Lidocaine 1ml)，The endpoint for embolization was defined as stagnation of blood flow of the posterior mesenteric artery. Intervention cycle：4W; Treatment times: 2. followed by mFOLFOX6

Study group

Neoadjuvant Chemotherapy DRUG

mFOLFOX6, Q2W

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gang Wu: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Central Study Contacts

Gang Wu, M.D.

CONTACT

+86 13938570175; wuganghenan2015@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share