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

May 17, 2022 updated by: Gang Wu
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer
Drug: Transarterial Chemoembolization
Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy evaluation
Time Frame: up to 3 years
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
Surgical resection rate
Time Frame: up to 3 years
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
PFS
Time Frame: up to 3 years
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
OS
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.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gang Wu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2025

Study Registration Dates

First Submitted

April 29, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 24, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TACE-GC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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