Biliary tract cancer is a highly aggressive and heterogeneous group of gastrointestinal cancers that arise from the intra- or extrahepatic bile ducts (CCA), or the gallbladder (GBC)(1-3). While it accounts for only 0.7% of all malignant tumors and 3% of all gastrointestinal malignancies in adults, both incidence and mortality are increasing. Biliary tract cancers usually present at an advanced stage, with only approximately 20% of patients being diagnosed with an early-stage disease (1, 2, 4). There is a high risk of recurrence post curative radical resection, with 60-70% of patients recurring within 5 years, with 5-year survival of around 25% (1, 2, 5). There is evidence for use of adjuvant chemotherapy with fluoropyrimidine- based regimens as per the BILCAP and ASCOT phase III trials \[(5-7).However, despite advances in adjuvant treatment, recurrence rates after resection of BTC remain high even with adjuvant chemotherapy. For example, in the BILCAP study, 5-year RFS was reported as 33.9% (95% CI: 27.6 to 40.2) (1). Therefore, an unmet need exists to optimize peri-operative treatment to reduce recurrence and improve outcomes in patients with resectable BTC.
Patient must be capable of providing written informed consent.
Age >18 years at time of study entry
Histologically proven intrahepatic cholangiocarcinoma
Complete surgical resection of the tumor must be achievable*. Resection should include a portal lymphadenectomy as per standard of care.
Radiological evidence suggesting inability to resect with curative intent whilst maintaining adequate vascular inflow and outflow
Radiological evidence of direct invasion into adjacent organs.
Radiological evidence of extrahepatic metastatic disease (except regional lymph nodes - stations 9 and 12
Contraindication to any of the study drugs
Single group
Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
Drug: Patients will receive prior to surgery: 2 cycles of combinational therapy with Gemcitabine (800mg) /Cisplatin (25mg) /Nab-Paclitaxel (100mg) and Rilvegostomig (Q3W). Post-surgical resection, adjuvant therapy will consist of 4 cycles of Gemcitabine (1000mg) /Cisplatin (25mg) and Rilvegostomig (Q3W). Rilvegostomig (Q3W) will be continued for a total of 12 months in the adjuvant phase
Major pathological response (MPR), defined as >70% tumor necrosis
To determine pathological response rate to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig in resected tumour
Objective response rate (ORR)
To determine the radiologic objective response rate (ORR) to neoadjuvant Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig.
The number of patients who experience a surgical delay and/or drop off due to treatment related adverse events (TRAEs) or progressive disease
To assess feasibility of pre-operative treatment of Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig
The number of ≥ grade 3 adverse events (AEs) or immune related adverse events that occur during treatment
To assess safety of pre-operative treatment with Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig.
Rate of R0
Number of resections with negative margins
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University Health Network, Toronto
Lead sponsor
Sunnybrook Health Sciences Centre
Collaborator
Hamilton Health Sciences Corporation
Collaborator
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