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

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03822130
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Successful Conversion Rate of Operation; Unresectable Gastric Cancer	Drug: Arterial catheter infusion chemotherapy; Drug: Sodium Bicarbonate; Drug: Systemic Chemotherapy; Drug: Oral Chemotherapy	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial for Intra-arterial Infusion Chemotherapy Combined With Sodium Bicarbonate and Systemic Chemotherapy for Unresectable Gastric Cancer
• Actual Study Start Date: Feb 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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: Arterial catheter infusion chemotherapy; Arterial catheter infusion chemotherapy; Drug: Oral Chemotherapy; Oral Chemotherapy
Experimental: Group 3 Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group	Drug: Arterial catheter infusion chemotherapy; Arterial catheter infusion chemotherapy; Drug: Sodium Bicarbonate; Arterial catheter infusion Sodium Bicarbonate; Drug: Oral Chemotherapy; Oral Chemotherapy

Outcome Measures

Primary Outcome Measures

1. Successful conversion rate of operation [42 days]

Secondary Outcome Measures

1. ORR [42 days]

   Objective Response rate

2. PFS [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT03822130
• Other Study ID Numbers: IR2018001142
• First Posted: Jan 30, 2019
• Last Update Posted: Feb 20, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stomach Neoplasms

Study Results

No Results Posted as of Feb 20, 2019