Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer

February 18, 2019 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged 18 to 75 years;
  2. Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy;
  3. Pathological diagnosis of gastric cancer;
  4. No contraindication of chemotherapy;
  5. Patients who did not undergo chemotherapy or were diagnosed for the first time.

Exclusion Criteria:

  1. 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;
  2. The life expectancy of patients with extensive systemic metastasis is less than 3 months;
  3. Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L;
  4. Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;
  5. Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department;
  6. Patients with distant metastasis (excluding group 16 lymph node metastasis);
  7. Patients with other tumors, with a history of malignant tumors (excluding early primary cancers);
  8. The patient himself asked to withdraw from the trial;
  9. Researchers believe that patients are not suitable for this study.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group 1
Systemic Chemotherapy + Oral Chemotherapy Group
Drug: Systemic Chemotherapy
Systemic Chemotherapy
Drug: Oral Chemotherapy
Oral Chemotherapy
EXPERIMENTAL: Group 2
Arterial catheter infusion chemotherapy plus oral chemotherapy group
Drug: Oral Chemotherapy
Oral Chemotherapy
Drug: Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
EXPERIMENTAL: Group 3
Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Drug: Oral Chemotherapy
Oral Chemotherapy
Drug: Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
Drug: Sodium Bicarbonate
Arterial catheter infusion Sodium Bicarbonate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful conversion rate of operation
Time Frame: 42 days
42 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
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
progression-free survival
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
ORR
Time Frame: 42 days
Objective Response rate
42 days

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

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 (ACTUAL)

February 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (ACTUAL)

January 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR2018001142

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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