First-Line Treatment for Advanced or Inoperable Biliary Tract Cancer (Cholangiocarcinoma)

This protocol addresses the management of cholangiocarcinoma when the disease is advanced or not amenable to surgery, and the patient has adequate performance status — the clinical setting in which first-line systemic therapy is appropriate.

Clinical Scenario Advanced or inoperable biliary tract cancer (cholangiocarcinoma) in a patient with adequate performance status. Surgical resection is not an option, and systemic therapy is indicated.

Treatment Approach (partial — see full protocol) Evidence-based first-line management involves a combination systemic chemotherapy regimen as the standard backbone; additional agents may be incorporated depending on approval status and availability. Specific substitutions are recommended when particular patient-level factors are present. The complete regimen, sequencing, and decision algorithm are in the full protocol.

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References

Cisplatin plus gemcitabine (CisGem) chemotherapy is recommended as the first-line treatment in patients with advanced biliary tract cancer (BTC).

CisGem chemotherapy is recommended as the first-line treatment in patients with advanced BTC.

Immunotherapy may be added to CisGem chemotherapy, if approved and available, cognisant of the magnitude of benefit and toxicities.

Use of gemcitabine alone in patients with poor performance status would be reasonable and substitution of oxaliplatin for cisplatin is reasonable in those with renal impairment.

Combination chemotherapy is recommended in patients with adequate performance status following failure of first-line chemotherapy, particularly in the absence of a targetable molecular alteration.

DOI: 10.1136/gutjnl-2023-330029

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