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

Primary Purpose

Colorectal Cancer

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

TACE protocol

Neoadjuvant Chemotherapy

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

Control group

Arm Description

sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy

neoadjuvant chemotherapy alone

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ORR

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)

The time from recruitment to death due to any cause.

Pathological response rate (PCR+MPR)

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.

Full Information

NCT ID

NCT05340231

First Posted

April 15, 2022

Last Updated

April 15, 2022

Sponsor

Gang Wu

1. Study Identification

Unique Protocol Identification Number

NCT05340231

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2022 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gang Wu

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

neoadjuvant chemotherapy alone

Intervention Type

Drug

Intervention Name(s)

TACE protocol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Neoadjuvant Chemotherapy

Intervention Description

mFOLFOX6, Q2W

Primary Outcome Measure Information:

Title

PFS

Description

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

Time Frame

up to 3 years

Secondary Outcome Measure Information:

Title

ORR

Description

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

Time Frame

up to 3 years

Title

Overall survival (OS)

Description

The time from recruitment to death due to any cause.

Time Frame

up to 3 years

Title

Pathological response rate (PCR+MPR)

Description

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.

Time Frame

up to 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gang Wu, M.D.

Phone

+86 13938570175

wuganghenan2015@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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