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The purpose of this clinical trial is to investigate whether the drug Shenqi Fuwei Mixture is effective for postoperative recurrence and metastasis of gastric cancer. Safety of Shenqi Fuwei Mixture will also be understood. It aims to answer the main questions:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenqi Fuwei Mixture | Experimental | Shenqi Fuwei Mixture |
|
| Shenqi Fuwei Mixture Placebo | Placebo Comparator | Shenqi Fuwei Mixture Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenqi Fuwei Mixture | Drug | Shenqi Fuwei Mixture |
| |
| Measure | Description | Time Frame |
|---|---|---|
| EFS | Event-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 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical conversion rate | Binary classification variables were used to calculate the proportion of patients who could undergo surgery, whichever came first, assessed up to 60 months | |
| OS | Overall Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bowen Xu, Dr. | Contact | +8618811732383 | xubowen@hnca.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Multicenter, large-sample, randomized, double-blind, placebo-controlled clinical study
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Subjects, investigators, image assessors, and statistical analysts were blinded and emergency letters were set up to unblind.
| Shenqi Fuwei Mixture Placebo |
| Drug |
Shenqi Fuwei Mixture Placebo |
|
| From date of randomization until the date of death from any cause, whichever came first, assessed up to 60 months |
| Tumor markers | CEA、CA724、CA199、CA125 | "Baseline" or "3 week" |
| DFS | Disease-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 60 months |
| Infections and complications | Perioperative/Periprocedural |
| FACT-Ga Scale | Functional Assessment of Cancer Therapy--Gastric cancer Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome. | "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)" |
| Adverse events | At the end of Cycle 1 (each cycle is 21 days) |
| ESAS Scale | Edmonton Symptom Assessment Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome. | "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)" |
| MDASI-TCM Scale | M.D.Anderson Symptom Inventory Traditional Chinese Medicine Scale. minimum and maximum values: 0-100, and higher scores mean a better outcome. | "Baseline" or "At the begin of Cycle 1 (each cycle is 21 days)" |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |