Back to resultsIntra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
Primary Purpose
Successful Conversion Rate of Operation, Unresectable Gastric Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Arterial catheter infusion chemotherapy
Sodium Bicarbonate
Systemic Chemotherapy
Oral Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Successful Conversion Rate of Operation
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 to 75 years;
- Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
- Pathological diagnosis of gastric cancer;
- No contraindication of chemotherapy;
- Patients who did not undergo chemotherapy or were diagnosed for the first time.
Exclusion Criteria:
- Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
- The life expectancy of patients with extensive systemic metastasis is less than 3 months;
- Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;
- Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
- Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
- Patients with distant metastasis (excluding group 16 lymph node metastasis);
- Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
- The patient himself asked to withdraw from the trial;
- Researchers believe that patients are not suitable for this study.
Sites / Locations
- The Second affiliated Hospital, Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Arm Description
Systemic Chemotherapy + Oral Chemotherapy Group
Arterial catheter infusion chemotherapy plus oral chemotherapy group
Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Outcomes
Primary Outcome Measures
Successful conversion rate of operation
Secondary Outcome Measures
ORR
Objective Response rate
PFS
progression-free survival
Full Information
NCT ID
NCT03822130
First Posted
January 23, 2019
Last Updated
February 18, 2019
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03822130
Brief Title
Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
Official Title
A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This project intends to compare the clinical effects and side effects of three kinds of treatment methods in the treatment of unresectable gastric cancer by intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate and systemic chemotherapy. It is clear that intra-arterial catheter infusion chemotherapy combined with sodium bicarbonate is not suitable for the treatment of unresectable gastric cancer. The clinical practice value of resection of gastric cancer can provide high quality evidence-based medical basis for the treatment guidelines of advanced gastric cancer, and explore a new clinical technology with exact curative effect and higher safety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Successful Conversion Rate of Operation, Unresectable Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Systemic Chemotherapy + Oral Chemotherapy Group
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Arterial catheter infusion chemotherapy plus oral chemotherapy group
Arm Title
Group 3
Arm Type
Experimental
Arm Description
Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Intervention Type
Drug
Intervention Name(s)
Arterial catheter infusion chemotherapy
Intervention Description
Arterial catheter infusion chemotherapy
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Arterial catheter infusion Sodium Bicarbonate
Intervention Type
Drug
Intervention Name(s)
Systemic Chemotherapy
Intervention Description
Systemic Chemotherapy
Intervention Type
Drug
Intervention Name(s)
Oral Chemotherapy
Intervention Description
Oral Chemotherapy
Primary Outcome Measure Information:
Title
Successful conversion rate of operation
Time Frame
42 days
Secondary Outcome Measure Information:
Title
ORR
Description
Objective Response rate
Time Frame
42 days
Title
PFS
Description
progression-free survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 to 75 years;
Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
Pathological diagnosis of gastric cancer;
No contraindication of chemotherapy;
Patients who did not undergo chemotherapy or were diagnosed for the first time.
Exclusion Criteria:
Those who fail to comply with the requirements of the trial, obviously violate this regimen, or change to other regimens in the course of treatment;
The life expectancy of patients with extensive systemic metastasis is less than 3 months;
Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;
Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
Patients with distant metastasis (excluding group 16 lymph node metastasis);
Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
The patient himself asked to withdraw from the trial;
Researchers believe that patients are not suitable for this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Chao
Phone
+86 13957139239
Email
z2doctor_chaoming@163.com
Facility Information:
Facility Name
The Second affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Chao
Phone
+86 13957139239
Email
z2doctor_chaoming@163.com
12. IPD Sharing Statement
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Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
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