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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Systemic Chemotherapy + Oral Chemotherapy Group |
|
| Group 2 | Experimental | Arterial catheter infusion chemotherapy plus oral chemotherapy group |
|
| Group 3 | Experimental | Arterial catheter infusion chemotherapy + sodium bicarbonate plus oral chemotherapy group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial catheter infusion chemotherapy | Drug | Arterial catheter infusion chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful conversion rate of operation | 42 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Chao | Contact | +86 13957139239 | z2doctor_chaoming@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second affiliated Hospital, Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
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| Sodium Bicarbonate | Drug | Arterial catheter infusion Sodium Bicarbonate |
|
| Systemic Chemotherapy | Drug | Systemic Chemotherapy |
|
| Oral Chemotherapy | Drug | Oral Chemotherapy |
|
| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D020360 | Neoadjuvant Therapy |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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