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

Last updated: February 18, 2019
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

1

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT03822130
IR2018001142
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients aged 18 to 75 years;

  2. Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastriccancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformationtherapy;

  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

Exclusion Criteria:

  1. Those who fail to comply with the requirements of the trial, obviously violate thisregimen, or change to other regimens in the course of treatment;

  2. The life expectancy of patients with extensive systemic metastasis is less than 3months;

  3. Leukocyte count is less than 2109/L and platelet count is less than 7510^9/L;

  4. Severe heart, liver and kidney diseases, unable to tolerate chemotherapy;

  5. Patients without gastric cancer complications such as massive gastrointestinalbleeding 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 earlyprimary cancers);

  8. The patient himself asked to withdraw from the trial;

  9. Researchers believe that patients are not suitable for this study.

Study Design

Total Participants: 150
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • The Second affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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