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

Study Overview
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Brief Summary
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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.

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

Conditions
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Successful Conversion Rate of Operation, Unresectable Gastric Cancer

Intervention / Treatment
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* Drug: Arterial catheter infusion chemotherapy
* Drug: Sodium Bicarbonate
* Drug: Systemic Chemotherapy
* Drug: Oral Chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 75 years; Ultrasound gastroscopy or imaging (CT) can diagnose potentially unresectable gastric cancer (T4a-bN2-3M0) with indications of neoadjuvant chemotherapy or transformation therapy; Pathological diagnosis of gastric cancer; No contraindication of chemotherapy; Patients who did not undergo chemotherapy or were diagnosed for the first time. Exclusion Criteria: 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; The life expectancy of patients with extensive systemic metastasis is less than 3 months; Leukocyte count is less than 2*109/L and platelet count is less than 75*10^9/L; Severe heart, liver and kidney diseases, unable to tolerate chemotherapy; Patients without gastric cancer complications such as massive gastrointestinal bleeding and perforation need to be treated in emergency department; Patients with distant metastasis (excluding group 16 lymph node metastasis); Patients with other tumors, with a history of malignant tumors (excluding early primary cancers); The patient himself asked to withdraw from the trial; Researchers believe that patients are not suitable for this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group 1<br>Systemic Chemotherapy + Oral Chemotherapy Group | Drug: Systemic Chemotherapy<br>* Systemic Chemotherapy<br>Drug: Oral Chemotherapy<br>* Oral Chemotherapy<br>|
| Experimental: Group 2<br>Arterial catheter infusion chemotherapy plus oral chemotherapy group | Drug: Arterial catheter infusion chemotherapy<br>* Arterial catheter infusion chemotherapy<br>Drug: Oral Chemotherapy<br>* Oral Chemotherapy<br>|
| Experimental: Group 3<br>Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group | Drug: Arterial catheter infusion chemotherapy<br>* Arterial catheter infusion chemotherapy<br>Drug: Sodium Bicarbonate<br>* Arterial catheter infusion Sodium Bicarbonate<br>Drug: Oral Chemotherapy<br>* Oral Chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful conversion rate of operation |  | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Response rate | 42 days | 
| 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 |