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Every dated change on the records linked to Gallbladder cancer, newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
Zanidatamab (HERIZON-BTC-01: 41 percent response, 53 percent gallbladder cancer; FDA 2024, EU 2025, MHRA February 2026, NICE TA1153 May 2026) or trastuzumab deruxtecan for IHC 3+ (DESTINY-PanTumor02 biliary cohort 45 percent response; FDA tumour-agnostic 2024, not NICE-appraised); trastuzumab with pertuzumab through the UK DETERMINE platform; first-line zanidatamab within HERIZON-BTC-302 and SAFIR-ABC10. (NCCN Category 2A)
285 incidental cancers and 516 operated patients across 24 centres, 2014 to 2022; 67.7 percent of incidental cancers had liver resection.
OS 14.
376 Indian patients (Suryavanshi et al.) and 56 Chilean tumours (Erices et al.) give the high-incidence regions their own frequencies.
36-month survival 14.6 vs 6.9 percent with durvalumab. Residual disease hazard ratios of 26 (2025) and 15.86 (2026) in two cohorts.
HER2+ (IHC 3+) unresectable/metastatic biliary tract cancer, previously treated
Gemcitabine and cisplatin with durvalumab (TOPAZ-1, in which 25 percent of patients had gallbladder cancer; NICE TA944) or with pembrolizumab (KEYNOTE-966; not appraised by NICE), with molecular profiling including HER2 at diagnosis and biliary drainage first if jaundiced. Second-line, HER2-directed and other targeted options follow in the rows below.
OS 6.
FDA accelerated approval (November 2024) on HERIZON-BTC-01, in which gallbladder cancer was the largest subgroup.
Locally advanced unresectable or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (KEYNOTE-966)
Biliary drainage by ERCP metal stent, percutaneous transhepatic drainage for hilar block or failed ERCP, or EUS-guided drainage (non-inferior to ERCP with fewer complications in a 125-patient randomised trial); duodenal stent or gastrojejunostomy for gastric outlet obstruction by expected survival (SUSTENT); opioids with coeliac plexus block for visceral pain; paracentesis or tunnelled catheter for ascites; early integrated palliative care. (NCCN Category 2A)
3-year overall survival 77.
Endometrial ORR 57.
Confirmed ORR by independent central review 41.
OS 12.
Zanidatamab response rate 41.3 percent in HER2-positive disease after chemotherapy.
A milestone in how this cancer is treated.
Locally advanced or metastatic biliary tract cancer (gallbladder cancer included) with gemcitabine and cisplatin (TOPAZ-1)
Cholecystectomy for polyps of 10 mm or more, or 6 to 9 mm with a risk factor; ultrasound surveillance at 6, 12 and 24 months otherwise; no follow-up for polyps of 5 mm or less without risk factors (ESGAR, EAES, EFISDS and ESGE 2022).
OS HR 0.
ORR 9.
ESGAR, EAES, EFISDS and ESGE set size and risk-factor rules for cholecystectomy and ultrasound follow-up.
244 samples: TP53 63%, CDKN2A 21%, ERBB2 15%, KRAS 11%, actionable alterations in 35% of patients (Giraldo et al., Clinical Cancer Research).
First immunotherapy survival benefit in biliary tract cancer; FDA approval September 2022.
FOLFOX with active symptom control (ABC-06, UK: overall survival 6.2 versus 5.3 months; gallbladder cancer eligible); liposomal irinotecan with fluorouracil is an NCCN option on NIFTY but was negative in NALIRICC and is not commissioned in the UK; trials preferred (SEVILLA ivonescimab versus FOLFOX at UCL; ComboMATCH for MAPK-mutant disease). (NCCN Category 1 (FOLFOX))
BICR PFS 7.
Median overall survival 6.2 vs 5.3 months; one-year survival 25.9 vs 11.4 percent. NIFTY (liposomal irinotecan) published the same year.
Biliary cohort ORR 5.
Biliary cohort ORR 51% (22/43, investigator) and 47% (independent review); grade 3 or worse GGT rise 12%.
167 tumours from Korea, India and Chile: ELF3 frameshift neoantigens, CTNNB1, STK11 and Wnt alterations (Pandey et al., Nature Communications).
Adjuvant capecitabine for six months (BILCAP, a UK trial in a mixed biliary population that required muscle-invasive gallbladder cancer for entry); the BILCAP record carries the figures, and the UK CAPBIL cohort saw no matched benefit, so ACTICCA-1 is awaited.
Modified FOLFOX plus active symptom control modestly improved overall survival over active symptom control alone.
Median PFS 11.
Six months of capecitabine after resection of biliary tract cancer becomes the adjuvant standard.
The digestive system volume standardises the nomenclature of gallbladder carcinoma and its precursors (biliary intraepithelial neoplasia, intracholecystic papillary neoplasm).
A stent placed by ERCP, or through the skin (PTC), is the usual way to relieve jaundice; metal stents stay open longer than plastic and are used when surgery to remove the cancer is not planned; a surgical bypass (joining the bile duct above the blockage to the small bowel) is reserved for people already having an operation or when a stent cannot be placed. Jaundice must be relieved before chemotherapy can be given safely.
OS 51.
T2 is split into T2a and T2b and N stage is defined by the number of involved nodes (N1 one to three, N2 four or more).
The Indian genome-wide association study finds common variants at ABCB1 and ABCB4 that raise gallbladder cancer risk.
Ethun and colleagues, ten US centres, 207 patients; a 2026 individual patient data meta-analysis found no difference by timing.
Radical (extended) cholecystectomy: resection of the liver bed (wedge or segments IVb and V) with portal lymphadenectomy, bile duct resection only when the cystic duct margin is positive; re-resection 4 to 8 weeks after an incidental diagnosis; port sites not routinely excised.
Urgent direct-access ultrasound for an upper abdominal mass consistent with an enlarged gallbladder (NICE NG12 1.2.10); urgent referral for jaundice; the UK pathway page carries the detail.
2-year OS 65% (R0 67%, R1 60%); median OS 35 months; grade 3 and 4 toxicity 52% and 11%.
260 Japanese biliary cancers: FGFR2 fusions intrahepatic, APOBEC signature and ELF3 in gallbladder and extrahepatic tumours (Nakamura et al., Nature Genetics).
Shindoh and colleagues' international series (437 patients) separates peritoneal-side from hepatic-side T2 disease: five-year survival 42.6 versus 64.7 percent.
79 patients, two-year survival 65 percent; no randomised trial has followed.
OS 11.
The AJCC 7th edition stages carcinoma of the cystic duct with gallbladder cancer.
ABC-02 (NEJM 2010) in a mixed biliary population including gallbladder cancer.