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Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Fruquintinib Combined with Standard Chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fruquintinib | Drug | Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year recurrence-free survival rate | Percentage of recurrence-free patients within 3 years of surgery | Three years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the start of treatment to the date of death from any cause | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up,whichever came first, assessed up to 3 years" |
| AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Ma, M.D. | Contact | +8613703923592 | mafeizzu@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Fei Ma, M.D. | Working relationship | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
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| ID | Term |
|---|---|
| C000591844 | HMPL-013 |
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Patients' blood and non-blood abnormal values or conditions were collected according to the frequency of visits per cycle and recorded for evaluation using CTCAE5.0 criteria |
| from the first drug administration to within 30 days for the last dose |