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

Gang Wu

Status and phase: Not yet enrolling; Phase 2

Conditions: Embolization; Gastric Cancer

Treatments: Drug: Transarterial Chemoembolization

Study type: Interventional

Funder types: Other

Identifiers

NCT05361161

TACE-GC-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer

Experimental group

Treatment:

Drug: Transarterial Chemoembolization