Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567600
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Low-dose Gemcitabine and Cisplatin and PD-1PD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Combined Therapy Using Low-dose Gemcitabine and Cisplatin Chemotherapy and PD-1PD-L1Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma an Open-label Multicenter Single-arm Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this phase 2 study researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1PD-L1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma
Detailed Description:
More and more studies suggest that low-dose chemotherapy has the ability to reshape the tumor microenvironment and promote tumor immunotherapy in a variety of tumors supporting the rationality of combining low-dose chemotherapy with immunotherapy to effectively treat tumors with low T cell infiltration More than half of intrahepatic cholangiocarcinomas are non-inflammatory quotcold tumorsquot and their unique immunosuppressive microenvironment is one of the reasons for the poor response rate to immunotherapy Low-dose chemotherapy can transform quotcoldquot tumors with low immunogenicity and poor immune cell infiltration into quothotquot tumors with immune responsiveness and sufficient immune cell infiltration enhance the effect of ICIs on tumor cells and minimize systemic toxicity thus preserving a quottherapeutic windowquot for combined immunotherapytargeted therapy Preclinical and clinical studies have shown that it is necessary to study the optimal dose of chemotherapeutic drugs in combination therapy In combination therapy long-term adequate doses of chemotherapeutic drugs may be unnecessary because this will not only lead to more severe toxicity but also damage rather than enhance anti-tumor immunity
To determine the efficacy and safety of low-dose chemotherapy combined with PD-1PD-L1 inhibitors in the treatment of patients with advanced intrahepatic cholangiocarcinoma we designed an open-label prospective multicenter single-arm clinical study of low-dose gemcitabine cisplatin combined with PD-1PD-L1 inhibitors in the treatment of patients with advanced intrahepatic cholangiocarcinoma
To determine the efficacy and safety of low-dose chemotherapy combined with PD-1PD-L1 inhibitors in the treatment of patients with advanced intrahepatic cholangiocarcinoma we designed an open-label prospective multicenter single-arm clinical study of low-dose gemcitabine cisplatin combined with PD-1PD-L1 inhibitors in the treatment of patients with advanced intrahepatic cholangiocarcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None