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

Early Phase 1

• Conditions: Successful Conversion Rate of Operation; Unresectable Gastric Cancer
• Interventions: Drug: Systemic Chemotherapy; Drug: Arterial catheter infusion chemotherapy; Drug: Sodium Bicarbonate; Drug: Oral Chemotherapy

• Registration Number: NCT03822130
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Study Start: 2019-02-01
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Systemic Chemotherapy	Systemic Chemotherapy + Oral Chemotherapy Group
Group 3	Sodium Bicarbonate	Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Group 3	Oral Chemotherapy	Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group
Group 1	Oral Chemotherapy	Systemic Chemotherapy + Oral Chemotherapy Group
Group 2	Arterial catheter infusion chemotherapy	Arterial catheter infusion chemotherapy plus oral chemotherapy group
Group 2	Oral Chemotherapy	Arterial catheter infusion chemotherapy plus oral chemotherapy group
Group 3	Arterial catheter infusion chemotherapy	Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group

Primary Outcome Measures

Name	Time	Method
Successful conversion rate of operation	42 days

Secondary Outcome Measures

Name	Time	Method
ORR	42 days	Objective Response rate
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

Trial Locations

Locations (1)

The Second affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China