HAIC With FOLFOX and Bevacizumab Plus Intravenous Toripalimab for Advanced BTC
|ClinicalTrials.gov Identifier: NCT04217954|
Recruitment Status : Not yet recruiting
First Posted : January 6, 2020
Last Update Posted : May 13, 2020
Biliary tract cancer includes gallbladder carcinoma and cholangiocarcinoma. Recently, the incidence of the biliary cancer is increasing, especially in China.
The prognosis of biliary tract cancer is poor. Only 20% patients are candidate to be performed surgery, and the median overall survival of the advanced biliary tract cancer is less than 6 months. Gemcitabine plus cisplatin were consider as the first-line chemotherapy regimen for advanced biliary tract cancer for many years. The objective response rate (ORR) after it is 26.1% and the median overall survival is less than 1 year.
Two years ago, a phase II study of hepatic arterial infusion chemotherapy with oxaliplatin and 5-fluorouracil for advanced perihilar cholangiocarcinoma finished in Peking University Cancer Hospital. The ORR in the study achieved 67.6% and the median overall survival achieved 20.5 months. In 2019, a retrospective study in Peking University Cancer Hospital showed that hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab for patients with unresectable intrahepatic cholangiocarcinoma has a ORR of 63.5% and the median overall survival achieved 14.5 months.
Programmed death-1 (PD-1) checkpoint inhibitor, like Toripalimab, can block the bind of PD-1 and PD-L1/PD-L2, then influence the immune response and recover the function of cytotoxic T lymphocytes. There are some studies indicate that the targeted agent of anti-angiogenesis, like bevacizumab, can adjust the immune microenvironment of the tumor to enhance the efficacy of the immunotherapy.
Likewise, the agents of chemotherapy can enhance the antigenicity of the tumor, and increase the ratio of CD8+ T cells in tumor microenvironment by the pattern of damage-associated molecular pattern (DAMP) so that have synergistic effect with PD-1 checkpoint inhibitor.
Recently, 9 patients with advanced biliary tract cancer received hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab in our center, and 3 of them lost to follow-up. Among the other 6 patients, the ORR and disease control rate achieved 83.3% and 100%, respectively.
In this study, investigators want to research the efficacy and safety of hepatic arterial infusion chemotherapy with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab for advance biliary tract cancer.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Biliary Tract Cancer||Other: oxaliplatin, 5-fluorouracil and bevacizumab plus Toripalimab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatic Arterial Infusion Chemotherapy With Oxaliplatin, 5-fluorouracil and Bevacizumab Plus Intravenous Toripalimab for Advanced Biliary Tract Cancer|
|Estimated Study Start Date :||May 15, 2020|
|Estimated Primary Completion Date :||June 15, 2022|
|Estimated Study Completion Date :||May 15, 2023|
Experimental: FOLFOX plus Bev plus Toripalimab
the patients enrolled in this arm would receive hepatic arterial infusion with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab
Other: oxaliplatin, 5-fluorouracil and bevacizumab plus Toripalimab
hepatic arterial infusion with oxaliplatin, 5-fluorouracil and bevacizumab plus intravenous Toripalimab
- Progression-free survival [ Time Frame: date from the first treatment to disease get progression, assessed at least 2 months ]date from the first treatment to disease get progression
- overall survival [ Time Frame: date from the first treatment to patients dead or lost to follow-up, assessed at least 6 months ]date from the first treatment to patients dead or lost to follow-up
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217954
|Contact: Xiaodong Wang, MDemail@example.com|
|Study Director:||Xiaodong Wang, MD||Department of Interventional Radiology, Peking University Cancer Hospital|