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

Gang Wu60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastric Cancer Embolization

Interventions

Transarterial ChemoembolizationDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Efficacy evaluation

Objective response rate (ORR): complete response (CR) + partial response (PR). Evaluation methods: Objective tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Subjects must have measurable tumor lesions at baseline, and the efficacy evaluation criteria are divided into complete remission (CR), partial remission (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1 criteria. Complete Remission (CR): All target and non-target lesions disappeared, no new lesions; Partial Remission (PR): Compared with baseline, tumor burden decreased by ≥30%, and non-target lesions did not progress significantly , no new lesions; Stable Disease (SD): neither PR nor PD; Progressive Disease (PD): tumor burden increased by ≥20%, and the absolute value increased by at least 5mm, or non-target lesions progressed, or new lesions (reconfirm progression after at least 6 weeks).

Time frame: up to 3 years

Surgical resection rate

Surgical resection rate: The rate of surgical resection is transformed from those who cannot undergo radical surgical resection and one-stage anastomosis after treatment.

Time frame: up to 3 years

PFS

Progression-free survival（PFS） is defined as the time between the date of randomization and any documented tumor progression or death from any cause.

Time frame: up to 3 years

Overall survival (OS), defined as the time from study entry (ie, signing the ICF) to death from any cause. For subjects who were alive at the last contact, their overall survival was censored on the date of the last contact.

Time frame: up to 3 years

Central Contacts

Gang Wu, MD

CONTACT

+86 13938570175 wuganghenan2015@163.com

Data from ClinicalTrials.gov

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