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

Unresectable Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03822130
• Other study ID #: IR2018001142
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ming Chao
• Phone: +86 13957139239
• Email: z2doctor_chaoming[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stomach Neoplasms
• Successful Conversion Rate of Operation
• Unresectable Gastric Cancer

Intervention

Drug:
• Arterial catheter infusion chemotherapy
Arterial catheter infusion chemotherapy
• Sodium Bicarbonate
Arterial catheter infusion Sodium Bicarbonate
• Systemic Chemotherapy
Systemic Chemotherapy
• Oral Chemotherapy
Oral Chemotherapy

Locations

Country	Name	City	State
China	The Second affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful conversion rate of operation		42 days
Secondary	ORR	Objective Response rate	42 days
Secondary	PFS	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