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Everything in development, the open problems and what is being done about them, the roadmaps, and what changed on this record.
What is in development for Gallbladder cancer, drawn from the whole corpus: 185 items. Drugs are grouped by the most advanced trial phase they have reached anywhere; approved treatments sit under standard of care. Technologies are the methods being tested for this cancer, trials are the studies recorded here, and ideas are proposals not yet in a trial.
No screening test and no surveillance programme even in the highest-incidence regions; ultrasound-based surveillance and cholecystectomy policies are unproven.
Background: CA 19-9. Also on OnCo: Symptoms and red flags · Early detection roadmap.
Whether T1b tumours need radical re-resection: no randomised trial exists, meta-analyses of retrospective cohorts disagree on disease-specific benefit, and the largest international series found five-year disease-specific survival of 93.7 versus 95.5 percent after simple versus extended cholecystectomy in 237 patients (Kim 2018); bile duct excision and port-site policy rest on the same kind of series.
Background: Tumour-agnostic (tissue-agnostic) approval. Also on OnCo: Find a trial · Expert centres.
How much liver to remove for T2 disease: a 2023 meta-analysis found better one-year disease-free survival but worse three-year overall survival and more complications with anatomical segment IVb and V resection than with a wedge, and two meta-analyses suggest peritoneal-side (T2a) tumours may not need the liver resection at all.
Background: Circulating tumour DNA (ctDNA). Also on OnCo: Treatment journeys · Survivorship planner.
Only about half of patients eligible for re-resection reached a specialist centre in the Dutch study that measured it, and two thirds had liver resection in the UK CAPBIL cohort; why the rest did not is not recorded.
UK survival and stage at diagnosis are not reported for gallbladder cancer outside Northern Ireland.
Why incidence is rising in the UK while falling in the United States is not explained.
The highest-incidence populations are the least sequenced: 23 Chilean patients in the largest comparative HER2 series and 56 Chilean tumours in the first landscape paper, against 244 samples from New York.
HER2 heterogeneity and loss at progression (Cowzer 2026) mean a positive biopsy does not guarantee benefit and a single diagnostic test may not describe the relapsed tumour.
Background: Circulating tumour DNA (ctDNA). Also on OnCo: Treatment journeys · Survivorship planner.
No immunotherapy biomarker works in gallbladder cancer: PD-L1 rates swing six-fold with the assay, MSI-high and TMB-high are rare, and the transcriptomic microenvironment subtypes have not been tested prospectively.
Background: Tumour-agnostic (tissue-agnostic) approval. Also on OnCo: Find a trial · Expert centres.
MDM2 and CCNE1 amplification, SMAD4 and STK11 loss, and ELF3 frameshift neoantigens are recurrent but untargeted in this disease.
Background: Circulating tumour DNA (ctDNA). Also on OnCo: Treatment journeys · Survivorship planner.
Neoadjuvant chemotherapy for incidental gallbladder cancer is untested: GAIN closed after 68 of 333 planned patients and OPT-IN will not report before 2028.
Gallbladder cancer is a quarter or less of the landmark first-line trials and their gallbladder hazard ratios are unpublished or exploratory; S1815 hinted at a gallbladder-specific taxane effect that no trial is designed to confirm.
HER2 positivity in gallbladder cancer ranges from 9 percent (Italian resected series scored by the HERIZON-BTC-01 rule, Angerilli 2026) through 13 percent (Chile, breast scoring, Roa 2014) to 31 percent (Japan, gastric scoring, Hiraoka 2020) depending on cohort and scoring rule, so the size of the zanidatamab-eligible population in the UK is uncertain.
Second-line evidence is thin: FOLFOX adds a month, liposomal irinotecan has one positive and one negative trial, and the UK's randomised second-line option is a single phase 2 (SEVILLA) at one site.
Why the map looks as it does: gallstones explain much of the excess in the Andes, the Gangetic belt and Pakistan but not the sex ratio of Korea and Japan, nor why India's south is spared; ancestry (Mapuche, Aymara, Native American), typhoid carriage, aflatoxin, mustard oil and water contamination are each supported by case-control studies and none by a prevention trial.
Adjuvant capecitabine's benefit is borrowed from BILCAP's mixed population; the UK CAPBIL cohort saw none in matched analysis. ACTICCA-1 and ARTEMIDE-Biliary01 are the tests.
Residual disease blood tests are strongly prognostic after biliary resection but no trial acts on them.
Background: Circulating tumour DNA (ctDNA). Also on OnCo: Treatment journeys · Survivorship planner.
Prevention in high-incidence regions: Chile's prophylactic cholecystectomy programme has run since 2006 without an evaluable design; typhoid carriers have never been offered a trial.
Dated changes read from the records linked to this cancer: approvals, regulatory steps, reported trials, guideline versions and milestones. Newest first; no date is inferred.
On EdgeAll 58 changes by month →When this page itself was last checked or edited.
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.