NCT04523402

Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Predict Risk of Lymph Node Metastasis

Oxaliplatin and Gemcitabine (GEMOX) Neoadjuvant Therapy for Resectable Intrahepatic Cholangiocarcinoma With High Risk of Lymph Node Metastasis as Preoperatively Evaluated by a Radiomics Model

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Eastern Hepatobiliary Surgery Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled, open label, phase II clinical trial is designed to target patients with resectable intrahepatic cholangiocarcinoma (ICC) with high risk of lymph node metastasis as evaluated by our previously established radiomics model, which has low postoperative recurrence-free survival. In this study, we aim to compare the prognosis of ICC patients who undergo liver resection (LR) following preoperative oxaliplatin and gemcitabine (GEMOX) neoadjuvant therapy (experimental arm) versus LR alone (control arm).

Detailed description

Intrahepatic cholangiocarcinoma (ICC) is the second most common liver cancer, and its incidence and mortality have been rising worldwide over the past two decades. Liver resection (LR) remains the only potentially curative treatment for ICC. However, the long-term outcome after LR is still dismal, and the 5-year survival after curative-intent resection was up to 35%. Lymph node (LN) metastasis is found in about 40% of ICC patients and is known to be one of the most important adverse prognostic factors. Considering such circumstances, it is crucial to determine the validity of routine LN dissection for ICC during LR, but there is so far no definitive evidence about the use of this surgical procedure. Preoperative individualized LN status assessment is beneficial for clinical decision of LN dissection and stratifying patients who may benefit from preoperative neoadjuvant therapy. The conventional and qualitative radiological characteristics in abdominal computerized tomography (CT) exhibited limited accuracy for preoperative assessment of LN status. Radiomics, a novel approach in medical image analysis, involves high-throughput extraction of quantitative image features and then associates these features with clinical concerns. The radiomic approach has been employed into preoperative diagnosis and prediction of prognosis. We have proposed a nomogram, incorporating conventional clinico-radiological characteristics and novel radiomic features in CT scan, provided accurate LN metastasis prediction in ICC patients and may aid the treatment decision making. Neoadjuvant therapy refers to some treatments taken before surgery for newly treated tumor patients who have not found distant metastasis, including chemotherapy, radiotherapy, targeted therapy, etc., to reduce tumors, reduce tumor stages, and reduce postoperative recurrence rate, prolonging survival time. As suggested by the results from previous studies, neoadjuvant chemotherapy with oxaliplatin plus gemcitabine for locally advanced ICC may be an effective downstaging option, facilitating secondary resectability in patients with initially unresectable disease (53%, 39 in 74 patients received secondary resection). In addition, for selected patients with locally advanced ICC who showed pre-transplant disease stability on neoadjuvant chemotherapy could obtain 50% 5-year recurrence-free survival and 83.3% 5-year overall survival. These evidences suggest that neoadjuvant chemotherapy with GEMOX regimen may be an ideal modality for patients with resectable ICC with high possibility of LN metastasis to reduce potential risk of recurrence, which is worth more investigation.

Conditions

• Intrahepatic Cholangiocarcinoma Recurrent

Interventions

Type	Name	Description
DRUG	Neoadjuvant chemotherapy	Neoadjuvant chemotherapy with GEMOX regimen before liver resection

Timeline

• Start date: 2020-12-31
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-08-21
• Last updated: 2020-08-21