Intrahepatic cholangiocarcinoma: current perspectives

Figures & data

Figure 1 Types of cholangiocarcinoma.

Note: Adapted by permission from Macmillan Publishers Ltd: Nat Rev Gastroenterol Hepatol. Blechacz B, Komuta M, Roskams T, Gores GJ. Clinical diagnosis and staging of cholangiocarcinoma. 2011;8(9):512–522. Copyright 2011.¹³⁴

Figure 2 Overall survival in a large cohort of intrahepatic cholangiocarcinoma patients.

Note: Reprinted from J Am Coll Surg, 221(2), Doussot A, Groot-Koerkamp B, Wiggers JK, et al., Outcomes after resection of intrahepatic cholangiocarcinoma: external validation and comparison of prognostic models, 452–461, Copyright (2015), with permission from Elsevier.⁴⁴
Abbreviation: AJCC, American Joint Committee on Cancer Staging.

Table 1 American Joint Committee on Cancer TNM classification, seventh edition

TNM stage	Definition
T stage
Tx	No description of the tumor’s extent is possible because of incomplete information
T0	There is no evidence of a primary tumor
T1	There is a single tumor that has grown into deeper layers of the bile duct wall, but it is still only in the bile duct.
	The cancer has not grown into any blood vessels
T2a	There is a single tumor that has grown through the wall of the bile duct and into a blood vessel
T2b	There are two or more tumors, which may (or may not) have grown into blood vessels
T3	The cancer has grown into nearby structures such as the intestine, stomach, common bile duct, abdominal wall, diaphragm (the thin muscle that separates the chest from the abdomen), or lymph nodes around the portal vein
T4	The cancer is spreading through the liver by growing along the bile ducts
N stage
Nx	Nearby (regional) lymph nodes cannot be assessed
N0	The cancer has not spread to nearby lymph nodes
N1	The cancer has spread to nearby lymph nodes
M stage
M0	The cancer has not spread to tissues or organs far away from the bile duct
M1	The cancer has spread to tissues or organs far away from the bile duct
Stage grouping
Stage I	T1, N0, M0
Stage II	T2, N0, M0
Stage III	T3, N0, M0
Stage IVa	T4, N0, M0/any T, N1, M0
Stage IVb	Any T, any N, M1

Table 2 Currently active phase III and phase IV studies

Title	Collaborators	Country/region	Interventions	No of patients	Outcome measures	Recruitment start	Completion date	NCT number
Palliative setting
Photodynamic Therapy (PDT) for Palliation of Cholangiocarcinoma	Weill Medical College of Cornell University	US	Photodynamic therapy	55	Efficacy profile, safety profile	Feb-12	Dec-16	NCT01755013
Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB	National Cancer Center, Korea	Korea	Early palliative care integrated with usual oncologic care	288	Reduction in pain scale, reduction in depression score, quality of life, overall survival	Apr-12	Jun-17	NCT01589328
Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally	The Christie NHS Foundation	UK	mFOLFOX	162	Overall survival, progression-free survival, response rate, toxicity, quality	Feb-14	Jan-18	NCT01926236
Advanced/Metastatic Biliary Tract Cancers	Trust|Cancer Research UK				of life, cost-effectiveness
Early Palliative Care With Standard Care or Standard Care Alone in Improving Quality of Life of Patients With Incurable Lung or Non-colorectal Gastrointestinal Cancer and Their Family Caregivers	Alliance for Clinical Trials in Oncology|National Cancer Institute (NCI)	US	Early palliative care	700	Reduction in depression, illness understanding, quality of life, rate of referral, length of hospice stay, location of death, ICU visits, number of patients treated with chemotherapy, overall survival, perceptions of cure	Apr-15	–	NCT02349412
RFA RCT for Pancreatic or Bile Duct Cancer	Weill Medical College of Cornell University	US	Radiofrequency ablation using EndoHPB probe vs stenting only	44	Clinical success, mutational profile of DNA	Jun-14	Jun-17	NCT02166190
Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma	Tata Memorial Hospital	India	High-dose radiation and systemic chemotherapy	155	Overall survival, progression-free survival, toxicity, quality of life, surgical resectability rates	May-15	Jun-22	NCT02773485
Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours	Centre Hospitalier Universitaire de Saint Etienne|Federation Francophone de Cancerologie Digestive	France	Gemcitabine and cisplatin vs mFOLFIRINOX	316	Progression-free survival, overall survival, response rate, toxicity	Nov-15	Jun-18	NCT02591030
Study of SPARC1507 (Sun Pharma Advanced Research Company Limited Drug)	Sun Pharma Advanced Research Company Limited	India	SPARC1507	198	Progression-free survival, overall survival, response rate	Apr-16	Nov-19	NCT02597465
Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy	Centre Oscar Lambret|Canceropôle Nord Ouest	France	Early palliative care	558	Overall survival, quality of life, reduction in depression score, time until definitive deterioration, advanced directives, number of patients treated with chemotherapy	Aug-16	Aug-20	NCT02853474
Adjuvant setting
Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Observation After Curative Intent Resection of Biliary Tract Cancer, ACTICCA	Universitätsklinikum Hamburg-Eppendorf|Deutsche Krebshilfe e.V., Bonn (Germany)|medac GmbH|Cancer Research UK|AGITG Australasian Gastro Intestinal Trials Group|KWF Kanker Bestrijding the Netherlands	Europe and Oceania	Gemcitabine and cisplatin	440	Disease-free survival, overall survival, toxicity, quality of life, function biliodigestive anastomosis, infections	Apr-14	Apr-22	NCT02170090
Oxaliplatin + Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma	Shanghai Zhongshan Hospital	People’s Republic of China	Gemcitabine and cisplatin	286	Recurrence-free survival, overall survival	Jul-15	Dec-18	NCT02548195

Abbreviations: FOLFOX, chemotherapy regimen consisting of folinic acid (leucovorin), 5-fluorouracil (5-FU), and oxaliplatin; FOLFIRINOX, chemotherapy regimen consisting of folinic acid (leucovorin), 5-fluorouracil (5-FU), irinotecan, and oxaliplatin; ICU, intensive care unit; RFA, radiofrequency ablation; RCT, randomized controlled trial.

Figure 3 Validated intrahepatic cholangiocarcinoma nomogram predicting overall survival. Adapted from Wang et al.⁴³

Note: Reprinted with permission. © 2013. American Society of Clinical Oncology. All rights reserved. Wang Y, Li J, Xia Y, et al, Prognostic nomogram for intrahepatic cho langiocarcinoma after partial hepatectomy, J Clin Oncol. 31(9):1188–1195.⁴³
Abbreviations: CEA, carcino-embryonic antigen; LN, lymph node; PI, periductal invasion.

BlechaczBKomutaMRoskamsTGoresGJClinical diagnosis and staging of cholangiocarcinomaNat Rev Gastroenterol Hepatol20118951252221808282

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DoussotAGroot-KoerkampBWiggersJKOutcomes after resection of intrahepatic cholangiocarcinoma: external validation and comparison of prognostic modelsJ Am Coll Surg2015221245246126206643

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WangYLiJXiaYPrognostic nomogram for intrahepatic cholangiocarcinoma after partial hepatectomyJ Clin Oncol20133191188119523358969

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