Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)

NCT ID: NCT05361161

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-12-01

Brief Summary

This is a prospective, open-labelled study to evaluate the efficacy and safety of sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of Initial unresectable gastric cancer.

Conditions

Gastric Cancer; Embolization

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer

Group Type: EXPERIMENTAL

Transarterial Chemoembolization

Intervention Type: DRUG

Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.

Interventions

Transarterial Chemoembolization

Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;

2. Age (18-80 years old) and gender are not limited;

3. No extragastric organ transfer;

4. No serious diseases of the heart, liver, lung, kidney and other organs;

5. Expected survival time > 3 months;

6. Physical performance status score ECOG ≤1 point;

7. Females of reproductive age must have a negative pregnancy test; or male and female patients must agree to use effective contraception during treatment and within 1 year thereafter.

Exclusion Criteria

1. Poor coagulation function, INR>1.5, or ongoing anticoagulation therapy or known bleeding diseases;

2. WBC <3000/mm3 or platelet count <50000/mm3;

3. AST and/or ALT > 3 times the upper limit of normal;

4. Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;

5. The patient has other primary tumors.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gang Wu

OTHER

Sponsor Role: lead

Responsible Party

Gang Wu

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Gang Wu, MD

Role: CONTACT

wuganghenan2015@163.com

+86 13938570175

Other Identifiers

TACE-GC-001

Identifier Type: -

Identifier Source: org_study_id