Abstract 81TiP
Background
Immunotherapy is a new treatment which has shown initial efficacy for cholangiocarcinoma patients (pts). Biliary radioactivity particle stent placement can effectively solve the obstruction of pts with advanced perihilar cholangiocarcinoma (PCC) and affect immune function, although the mechanism by which this occurs is not clear. Hepatic Arterial Infusion (HAI) treatment of advanced PCC can inhibit tumour growth, however, the impact on immune function needs to be explored. Therefore, the immune function and prognosis of advanced PCC pts who are receiving different therapies is worth further exploration.
Trial design
This study is a prospective, open-label, multi-cohort clinical study. Pts with advanced PCC (75 pts) are allocated to three cohorts (1:1:1) according to informed and voluntary consent. Cohort A: 125I particle stent + HAI + camrelizumab; Cohort B: 125I particle stent + camrelizumab; Cohort C: HAI + camrelizumab. Methods of particle implantation are dependent on patients' condition of disease (the size of the tumor/TPS plan before particle implantation etc.). HAI plan: HAI consisted of infusions of oxaliplatin 40 mg/ m2 for 2 hours, followed by 5-fluorouracil 800 mg/m2 for 22 hours on days 1∼3 every 3 weeks, a maximum of 6 cycles of HAI are applied for tumor control patients followed by maintenance with oral capecitabine until tumor progression. Camrelizumab (200mg) is administered every 3 weeks up to 12 months. Efficacy and safety are evaluated after 1 cycle first and every 3 cycles follow-up. Primary endpoints are objective response rate (ORR) and safety. Secondary endpoints includes progress free survival (PFS), near-term outcome indicators (TBIL/DBIL/AST/ALT/ CEA/CA199 etc.), long-term outcome indicators (stent patency rate/ tumour response rate etc.), complications (fever/ bleeding/pain etc.), changes in immune-inflammatory cytokines (TNF-α/IL-1β/IL-6/ IL-8/CD4/CD8/IgA/IgG/IgM/complement C3 and C4), etc.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.