Back to resultsTransarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
Primary Purpose
Gastric Cancer, Embolization
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Transarterial Chemoembolization
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
- Age (18-80 years old) and gender are not limited;
- No extragastric organ transfer;
- No serious diseases of the heart, liver, lung, kidney and other organs;
- Expected survival time > 3 months;
- Physical performance status score ECOG ≤1 point;
- 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:
- Poor coagulation function, INR>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
- WBC <3000/mm3 or platelet count <50000/mm3;
- AST and/or ALT > 3 times the upper limit of normal;
- Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
- The patient has other primary tumors.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer
Arm Description
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05361161
Brief Title
Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
Official Title
Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gang Wu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Embolization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transarterial Chemoembolization With Lipiodol for Initial Unresectable Gastric Cancer
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Transarterial Chemoembolization
Intervention Description
Arterial infusion chemotherapy (THP + oxaliplatin + raltitrexed) and THP combined with lipiodol embolization for 2 times, with an interval of 1 month.
Primary Outcome Measure Information:
Title
Efficacy evaluation
Description
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
Title
Surgical resection rate
Description
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
Title
PFS
Description
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
Title
OS
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pathological and imaging diagnosis of gastric adenocarcinoma with initial unresectable R0;
Age (18-80 years old) and gender are not limited;
No extragastric organ transfer;
No serious diseases of the heart, liver, lung, kidney and other organs;
Expected survival time > 3 months;
Physical performance status score ECOG ≤1 point;
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:
Poor coagulation function, INR>1.5, or ongoing anticoagulation therapy or known bleeding diseases;
WBC <3000/mm3 or platelet count <50000/mm3;
AST and/or ALT > 3 times the upper limit of normal;
Comorbidities or social environment that can cause subjects to fail to follow the research plan or even endanger patient safety;
The patient has other primary tumors.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Wu, MD
Phone
+86 13938570175
Email
wuganghenan2015@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transarterial Chemoembolization With Lipiodol in the Treatment of Initial Unresectable Gastric Cancer (GC)
We'll reach out to this number within 24 hrs