Latest Cancer TreatmentsDr. Mohammadreza Dabiri
Dr. Mohammadreza Dabiriفارسی
Treatment regimen

Gemcitabine-cisplatin with durvalumab in biliary tract cancer

The TOPAZ-1 regimen for cholangiocarcinoma and gallbladder cancer

Updated: 28 October 20261 min read3 references

Summary for doctors

  • First line in advanced biliary tract and gallbladder cancer [1].
  • Low-dose cisplatin (25 on days 1 and 8); up to 8 cycles, then durvalumab alone [1].
  • Before treatment, molecular testing (IDH1, FGFR2, HER2, MSI) for later lines.

Dose and schedule

Gem/Cis + durvalumab

Advanced biliary tract or gallbladder cancer, first line

Advanced biliary tract or gallbladder cancer, first line

DrugDoseRouteSchedule
Phase 1: up to 8 cycles
Gemcitabine1000 mg/m²IVDays 1 and 8
Cisplatin25 mg/m²IVDays 1 and 8
Durvalumab1500 mgIVDay 1 every 21 days
Phase 2
Durvalumab1500 mgIVEvery 28 days
Cycle length
Chemotherapy every 21 days; durvalumab alone every 28 days
Duration
Chemotherapy up to 8 cycles; durvalumab until progression

Doses as in TOPAZ-1 [1]; gemcitabine-cisplatin is the same regimen as ABC-02 [2].

Dose source: [3].

Evidence: TOPAZ-1 (2022), ABC-02 (2010)

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Premedication and supportive care

  • Hydration before and after cisplatin; 5-HT3 and dexamethasone antiemetics (low-dose cisplatin).
  • Teach the symptoms of immune-related toxicity (diarrhoea, rash, cough, jaundice).

Monitoring and dose adjustment

  • Blood counts before day 1 and day 8; creatinine and magnesium.
  • Distinguish cholangitis and stent blockage from drug toxicity (fever and rising bilirubin).
  • Liver enzymes and thyroid for immune-related toxicity.

Main evidence

Show detailsHide

ABC-02: gemcitabine-cisplatin vs gemcitabine increased median survival from 8.1 to 11.7 months [2]. TOPAZ-1: adding durvalumab increased median survival from 11.5 to 12.8 months (hazard ratio 0.80), and 2-year survival was about doubled [1].

Related cancer types

Liver cancerPancreatic cancer

Treatment regimens (physicians)

FOLFIRINOX and mFOLFIRINOX: dose and side effectsGemcitabine with nab-paclitaxel: dose and scheduleAtezolizumab with bevacizumab in liver cancerDurvalumab and tremelimumab in liver cancer (STRIDE)

Physician tools and lessons

Khorana Score (Cancer-Associated Thrombosis Risk)Child-Pugh and ALBI Score Calculator in Liver CancerGermline genetic testing in cancer: who, and which genes?

References

3 references
Show all references, 2 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    Durvalumab plus Gemcitabine and Cisplatin in Advanced Biliary Tract CancerOh DY, Ruth He A, Qin S, et al · NEJM Evid · 2022;1:EVIDoa2200015
    Study cardDOIPubMed Back to text: 1 2 3 4
  2. 2
    Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancerValle J, Wasan H, Palmer DH, et al · N Engl J Med · 2010;362:1273-81
    Study cardDOIPubMed Back to text: 1 2
  3. 3
    IMFINZI (DURVALUMAB) — Prescribing InformationAstrazeneca Pharmaceuticals LP · FDA label · 2026
    Source Back to text

This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.

Printed from the website; the full and up-to-date version: https://drdabiri.com/en/regimens/gemcitabine-cisplatin-durvalumab/

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