Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate for Unresectable Gastric Cancer
NCT ID: NCT03822130
Last Updated: 2019-02-20
Study Results
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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UNKNOWN
EARLY_PHASE1
150 participants
INTERVENTIONAL
2019-02-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Systemic Chemotherapy + Oral Chemotherapy Group
Systemic Chemotherapy
Systemic Chemotherapy
Oral Chemotherapy
Oral Chemotherapy
Group 2
Arterial catheter infusion chemotherapy plus oral chemotherapy group
Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
Oral Chemotherapy
Oral Chemotherapy
Group 3
Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
Sodium Bicarbonate
Arterial catheter infusion Sodium Bicarbonate
Oral Chemotherapy
Oral Chemotherapy
Interventions
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Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
Sodium Bicarbonate
Arterial catheter infusion Sodium Bicarbonate
Systemic Chemotherapy
Systemic Chemotherapy
Oral Chemotherapy
Oral Chemotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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The Second affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IR2018001142
Identifier Type: -
Identifier Source: org_study_id
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