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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05361161
• Other study ID #: TACE-GC-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2022
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Gang Wu, MD
• Phone: +86 13938570175
• Email: wuganghenan2015[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Embolization
• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gang Wu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	up to 3 years
Primary	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.	up to 3 years
Primary	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.	up to 3 years
Primary	OS	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.	up to 3 years