Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05198856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-01-20
First Post:
2021-11-18
Brief Title:
Thalidomide Combined With Chemotherapy and Monotherapy for Maintenance Treatment for Her2-negative Advanced GC
Sponsor:
Qilu Hospital of Shandong University
Organization:
Qilu Hospital of Shandong University
Study Overview
Official Title:
A Single-arm Open Prospective Multi-center Study on Thalidomide Combined With First-line Chemotherapy and Monotherapy for Maintenance Treatment of Liver Metastases From Her2-negative Advanced Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall incidence of liver metastases from gastric cancer is about 99-187 Gastric cancer has strong heterogeneity and rapid disease progression and the prognosis of liver metastasis is poor The 5-year survival rate of patients with liver metastases from gastric cancer is very low making clinical treatment challenging
Thalidomide has immunomodulatory and anti-angiogenesis effects It has been used in the treatment of multiple myeloma for more than 20 years and there are many clinical studies in solid tumors In recent years thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN Therefore it is very meaningful to explore the therapeutic value of thalidomide in advanced gastric cancer liver metastasis
Thalidomide has immunomodulatory and anti-angiogenesis effects It has been used in the treatment of multiple myeloma for more than 20 years and there are many clinical studies in solid tumors In recent years thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN Therefore it is very meaningful to explore the therapeutic value of thalidomide in advanced gastric cancer liver metastasis
Detailed Description:
The overall incidence of liver metastases from gastric cancer is about 99-187 Gastric cancer has strong heterogeneity and rapid disease progression and the prognosis of liver metastasis is poor The 5-year survival rate of patients with liver metastases from gastric cancer is very low making clinical treatment challenging Although immune checkpoint inhibitors have been approved for third-line treatment of advanced gastric cancer they are expensive and poorly accessible For patients with poor economic conditions combination therapy based on chemotherapy regimen or treatment regimen optimization may still be a relatively important direction
Thalidomide has immunomodulatory and anti-angiogenesis effects It has been used in the treatment of multiple myeloma for more than 20 years and there are many clinical studies in solid tumors In recent years thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN
In addition the sedative effect of thalidomide helps to improve patients sleep Thalidomide can also inhibit inflammatory factors such as TNF-α thus improving appetite and increasing lean body weight in patients with cachexia Its antiemetic effects can reduce gastrointestinal reactions to chemotherapeutic drugs in combined therapy Thalidomide is also very cheap in China which is suitable for patients on long-term maintenance treatment Therefore it is of great significance to explore the therapeutic value of thalidomide in liver metastasis of advanced gastric cancer
Thalidomide has immunomodulatory and anti-angiogenesis effects It has been used in the treatment of multiple myeloma for more than 20 years and there are many clinical studies in solid tumors In recent years thalidomide has been found to induce the degradation of IKAROS family transcription factors IKZF1 and IKZF3 in combination with CRBN
In addition the sedative effect of thalidomide helps to improve patients sleep Thalidomide can also inhibit inflammatory factors such as TNF-α thus improving appetite and increasing lean body weight in patients with cachexia Its antiemetic effects can reduce gastrointestinal reactions to chemotherapeutic drugs in combined therapy Thalidomide is also very cheap in China which is suitable for patients on long-term maintenance treatment Therefore it is of great significance to explore the therapeutic value of thalidomide in liver metastasis of advanced gastric cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None