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Introduction. In a quarter of patients with resectable intrahepatic cholangiocarcinoma (ICC) relapse occurs within six months after surgery, and the life prognosis for such patients is comparable to that of chemotherapy. The presence of negative prognostic factors, including non-radical resection, adversely affects long-term outcomes. The positive role of adjuvant treatment in patients with resectable cholangiocarcinoma has been shown in only one prospective phase III study (BILCAP). According to retrospective data, preoperative therapy may improve long-term outcomes.
Aim. To improve the treatment outcomes of patients with resectable ICC through the use of preoperative chemotherapy.
Materials and methods. The presented clinical study protocol was initiated at the N.N. Blokhin National Medical Research Center of Oncology of the Ministry of Health of Russia, and approved by the local ethics committee on December 22, 2022. In addition to the aforementioned institution, four other centers participated in the study. The clinical trial is registered on the portal https://db.oncoproct.ru (neoadjuvant chemotherapy in ICC).
It is a multicenter, prospective, randomized trial designed to assess the safety and efficacy of neoadjuvant chemotherapy in patients with resectable ICC compared to the standard treatment of liver resection without preoperative therapy.
Primary endpoint: R0 resection rate (95 %). Secondary endpoints: objective response rate, pathologic response, long-term outcomes, tolerability of preoperative chemotherapy, frequency and extent of post-resection complications after preoperative chemotherapy, compliance rate.
94 patients with resectable ICC are planned to be enrolled and randomized in a 1:1 ratio. Some patients will receive three cycles of systemic gemcitabine/cisplatin therapy. Others will have the regional drug delivery by intra-arterial chemoinfusion, followed by systemic administration on the eighth day of the cycle. The historical control will be used as the сomparison group. It will consist of patients with resectable ICC identified through examination data who underwent resection without preoperative therapy, achieving an R0 resection rate of 81.3 % in this cohort.
Conclusion. The presented study protocol will determine the safety and feasibility of preoperative chemotherapy in resectable ICC using gemcitabine and platinum-based agents, including intrahepatic infusion.
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