Biliary Tract Cancer Treatment Protocols 

Updated: Dec 30, 2015
  • Author: Jeffrey B VanDeusen, MD, PhD; Chief Editor: N Joseph Espat, MD, MS, FACS  more...
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Treatment Protocols

Treatment protocols for biliary tract cancer are provided below, including surgery, adjuvant therapies, systemic therapies, and single-agent regimens. [1, 2]

Surgical resection

See the list below:

  • Surgery is the only curative modality for biliary tract cancers; surgical resectability of disease should be established by care teams who are experts in the field
  • Criteria for resectability include absence of all of the following: retropancreatic and paraceliac nodal metastases or distant liver metastases, invasion of the portal vein or main hepatic artery (although some centers can offer vascular reconstruction), extrahepatic adjacent organ invasion, and disseminated disease
  • Surgical resection generally includes cholecystectomy, en bloc hepatic resection, and lymphadenectomy with or without bile duct excision, depending on the location of the tumor [3]
  • If cancer is found incidentally at the time of surgery for other reasons and resectability is not clearly established or if the surgeon is not trained in the operation, then delayed open laparotomy is appropriate, as there is not a survival deficit compared to immediate resection [4]

Neoadjuvant therapy

See the list below:

  • Neoadjuvant chemoradiotherapy is not currently a standard option for patients with biliary tract cancer
  • There is a small selected case series where 9 of 91 patients presenting with more advanced disease received chemoradiotherapy and all achieved an R0 resection [5] ; however, a later study investigating chemoradiotherapy with 5-FU did not show a survival benefit [5] ; more data are needed with longer follow-up before this approach can be recommended

Adjuvant therapy following curative-intent resection

Stage IB-III (T1-3, N0-1, M0):

  • Data for adjuvant chemotherapy in patients with biliary tract cancers is very poor and, overall, does not show a significant survival benefit, but there may be some selected patients who derive benefit
  • Adjuvant chemoradiotherapy with a fluoropyrimidine should be strongly considered for patients with T2 or greater disease, microscopic positive margins, or positive regional lymph nodes [6, 7]
  • Consideration can also be made for an additional 4mo of a fluoropyrimidine- or gemcitabine-based therapy in patients with extrahepatic cholangiocarcinoma with either positive margins or positive regional lymph nodes [8]
  • Recommendations for radiation therapy in the adjuvant setting stem from high rates of local failure following surgery, and a retrospective analysis of patients receiving adjuvant radiotherapy shows an initial survival benefit; however, a longer-term follow-up series suggests that this benefit may be lost after more than 5 years. [6]

Adjuvant chemoradiotherapy regimens for stage IB-III:

  • 5-FU 225 mg/m 2 IV daily during radiation [7] or
  • 5-FU 500 mg/m 2 IV bolus on days 1-3 and days 29-31 during radiation [9] or
  • Capecitabine 825 mg/m 2 PO twice daily during radiation [10] ; following radiation, consider an additional 4mo of therapy [8] or
  • Capecitabine 1000 mg/m 2 PO twice daily for 14 of every 21d [11] or
  • Capecitabine 800-900 mg/m 2 PO BID on days of radiation [9]
  • For those with aggressive or high-risk disease (positive margins) or multiple positive lymph nodes, consider switching to a gemcitabine-based regimen (see Systemic therapy, below).

Systemic therapy for nonresectable or metastatic disease

Selected stage III-IV (T3-4, Any N, M0-1):

Standard-of-care front-line chemotherapy for patients with good performance status (ECOG score ≤2): [12]

  • Cisplatin 25 mg/m 2 IV on days 1 and 8 plus  gemcitabine 1000 mg/m 2 IV on days 1 and 8; then every 21d for up to 24wk or until disease progression

Other acceptable regimens for good performance status patients (gemcitabine regimens favored): [13]

  • Gemcitabine 1000 mg/m 2 IV on day 1 plus  oxaliplatin 100 mg/m 2 IV on day 2; then every 14d until progression or toxicity [13] or
  • Gemcitabine 1000 mg/m 2 IV on days 1 and 8 plus  capecitabine 650 mg/m 2 PO on days 1-14; then every 21d until progression or toxicity [14] or
  • Capecitabine 1000 mg/m 2 PO twice daily on days 1-14 plus  oxaliplatin 130 mg/m 2 IV on day1; then every 21d until progression or toxicity [15] or
  • Leucovorin 400 mg/m 2 IV infused over 2h prior to 5-FU plus  5-FU 400 mg/m 2 IV bolus on day 1, followed by 2400 mg/m 2 IV infused over 46h plus  oxaliplatin 100 mg/m 2 IV on day 1; then every 14d until progression or toxicity [16, 17] or
  • Capecitabine 1250 mg/m 2 PO twice daily on days 1-14 plus  cisplatin 60 mg/m 2 IV on day 1; then every 21d until progression or toxicity [18] or
  • 5-FU 1000 mg/m 2/day via continuous IV infusion on days 1-5 plus  cisplatin 100 mg/m 2 IV on day 2; then every 4wk until progression or toxicity [19]

Single-agent regimens for patients with poorer performance status (ECOG score > 2) [14] :

  • Gemcitabine 1000 mg/m 2 IV on days 1 and 8; then every 21d until progression or toxicity [20, 21] or
  • Capecitabine 1000 mg/m 2 PO twice daily for 14d; then every 21d until progression or toxicity [11] or
  • 5-FU 425 mg/m 2 IV bolus plus  folinic acid 20 mg/m 2 IV; then weekly until progression or toxicity [22] or
  • Docetaxel 100 mg/m 2 IV; then every 21d until progression or toxicity [23]

Special considerations

See the list below:

  • Chemotherapy should generally be reserved for patients with good performance status
  • Palliative biliary drainage is often necessary in patients with advanced unresectable biliary tract carcinoma
  • Percutaneous biliary drainage is usually more successful and has a lower complication rate than endoscopic stenting [24]