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

NCT ID: NCT03822130

Last Updated: 2019-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Successful Conversion Rate of Operation Unresectable Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Systemic Chemotherapy + Oral Chemotherapy Group

Group Type PLACEBO_COMPARATOR

Systemic Chemotherapy

Intervention Type DRUG

Systemic Chemotherapy

Oral Chemotherapy

Intervention Type DRUG

Oral Chemotherapy

Group 2

Arterial catheter infusion chemotherapy plus oral chemotherapy group

Group Type EXPERIMENTAL

Arterial catheter infusion chemotherapy

Intervention Type DRUG

Arterial catheter infusion chemotherapy

Oral Chemotherapy

Intervention Type DRUG

Oral Chemotherapy

Group 3

Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group

Group Type EXPERIMENTAL

Arterial catheter infusion chemotherapy

Intervention Type DRUG

Arterial catheter infusion chemotherapy

Sodium Bicarbonate

Intervention Type DRUG

Arterial catheter infusion Sodium Bicarbonate

Oral Chemotherapy

Intervention Type DRUG

Oral Chemotherapy

Interventions

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Arterial catheter infusion chemotherapy

Arterial catheter infusion chemotherapy

Intervention Type DRUG

Sodium Bicarbonate

Arterial catheter infusion Sodium Bicarbonate

Intervention Type DRUG

Systemic Chemotherapy

Systemic Chemotherapy

Intervention Type DRUG

Oral Chemotherapy

Oral Chemotherapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Second affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ming Chao

Role: CONTACT

+86 13957139239

Facility Contacts

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Min Chao

Role: primary

+86 13957139239

Other Identifiers

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IR2018001142

Identifier Type: -

Identifier Source: org_study_id

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