Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446154
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-30
Brief Title:
FOLFOX Chemotherapy Plus Fruquintinib and Sintilimab After First-line Treatment in Unresectable Hepatocellular Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
FOLFOX Chemotherapy Oxaliplatin Fluorouracil and Leucovorin Fruquintinib and Sintilimab After First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma A Single-arm Single-center Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
FOLFOX
Brief Summary:
Nowadays there are few second-line treatment options for advanced hepatocellular carcinoma HCC In order to further improve the efficacy of second-line treatment for advanced HCC we plan to conduct a single-arm single-center and phase II clinical study to explore the efficacy and safety of the new second-line treatment for advanced HCC
Previous studies had shown that FOLFOX systemic chemotherapy tended to increase the median survival time of patients with advanced HCC and significantly improved the progression-free survival and tumor response rate Therefore FOLFOX systemic chemotherapy has become one of the recommended treatments for advanced HCC in Chinese guidelines
A phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment with a median progression-free survival of 74 months and a tumor response rate of 316 Furthermore there was a synergistic effect among chemotherapy immunotherapy and anti-angiogenic therapy Our previous phase II study showed that the median progression-free survival was 973 months the median overall survival time was 1463 months and the tumor response rate was 433 in HCC patients extrahepatic metastasis who received FOLFOX systemic chemotherapy combined with targeted and immunotherapy The results from our study suggested that the combination therapy had excellent anti-tumor efficacy and safety profile
Therefore We intend to conduct this clinical study to explore the efficacy and safety of FOLFOX systemic chemotherapy combined with fruquintinib and sintilimab in second-line treatment for patients with unresectable HCC after first-line treatment
Previous studies had shown that FOLFOX systemic chemotherapy tended to increase the median survival time of patients with advanced HCC and significantly improved the progression-free survival and tumor response rate Therefore FOLFOX systemic chemotherapy has become one of the recommended treatments for advanced HCC in Chinese guidelines
A phase II clinical study had showed that sintilimab combined with fruquintinib was with a promising anti-tumor activity in patients with advanced HCC who had received standard treatment with a median progression-free survival of 74 months and a tumor response rate of 316 Furthermore there was a synergistic effect among chemotherapy immunotherapy and anti-angiogenic therapy Our previous phase II study showed that the median progression-free survival was 973 months the median overall survival time was 1463 months and the tumor response rate was 433 in HCC patients extrahepatic metastasis who received FOLFOX systemic chemotherapy combined with targeted and immunotherapy The results from our study suggested that the combination therapy had excellent anti-tumor efficacy and safety profile
Therefore We intend to conduct this clinical study to explore the efficacy and safety of FOLFOX systemic chemotherapy combined with fruquintinib and sintilimab in second-line treatment for patients with unresectable HCC after first-line treatment
Detailed Description:
None
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