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CANCER:

Biliary Tract Cancer

Related cancers:
2d
CIBI354A101: A First-in-human Study of IBI354 in Subjects With Locally Advanced Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=368, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting | Trial completion date: Jul 2025 --> Oct 2025
Enrollment open • Trial completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 expression
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IBI-354
4d
Phase II study of Sintilimab combined with GS regimen for neoadjuvant treatment of locally advanced biliary tract cancer (BTC) (ChiCTR2400089592)
P2, N=38, Not yet recruiting, Shanghai Eastern Hepatobiliary Surgery Hospital; Shanghai Eastern Hepatobiliary Surgery Hospital
New P2 trial • Metastases
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Tyvyt (sintilimab)
4d
New P2 trial • Metastases
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cisplatin • gemcitabine • Kaitanni (cadonilimab)
4d
New P2 trial • Metastases
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5-fluorouracil • oxaliplatin • leucovorin calcium • Onivyde (nanoliposomal irinotecan) • Ariely (adebrelimab)
10d
Camrelizumab combined with gemcitabine and apatinib in treating advanced PD-L1-positive biliary tract cancers. (PubMed, Cancer Sci)
The most frequent grade 3 or 4 treatment-related adverse event was neutropenia (n = 4, 29%). The combination of camrelizumab, gemcitabine, and apatinib showed promising efficacy and acceptable safety in patients with advanced PD-L1-positive biliary tract cancer.
Journal • Metastases
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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gemcitabine • AiRuiKa (camrelizumab) • AiTan (rivoceranib)
14d
Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes (clinicaltrials.gov)
P=N/A, N=360, Recruiting, Cedars-Sinai Medical Center | Trial primary completion date: Jun 2025 --> Jan 2026
Trial primary completion date • Patient reported outcomes
16d
New P2/3 trial • Metastases
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5-fluorouracil • Focus V (anlotinib) • albumin-bound paclitaxel • oxaliplatin • leucovorin calcium • Teysuno (gimeracil/oteracil/tegafur)
17d
Ginsenoside Rg3 activates the immune function of CD8+ T cells via circFOXP1-miR-4477a-PD-L1 axis to induce ferroptosis in gallbladder cancer. (PubMed, Arch Pharm Res)
Ferroptosis inhibitor Fer-1 administration could reverse the beneficial effects caused by Rg3 treatment while ferroptosis inducer Erastin treatment enhanced the effects...Rg3 inactivated the circFOXP1-miR-4477a-PD-L1 signaling axis to activate the immune function of CD8+ T cells, thereby inducing ferroptosis and apoptosis in GBC cells. This research recognizes the mechanism of Rg3-mediated anti-cancer effect and offers evidence for the potentiality of Rg3 in clinical application for GBC therapy.
Journal • PD(L)-1 Biomarker • IO biomarker
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CD8 (cluster of differentiation 8)
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PD-L1 overexpression
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erastin
17d
A Study of Tumor-Treating Fields in Combination With Durvalumab and Gemcitabine/Cisplatin in Biliary Tract Cancers (clinicaltrials.gov)
P=N/A, N=60, Recruiting, Jiangsu Healthy Life Innovation Medical Technology Co., Ltd | Not yet recruiting --> Recruiting
Enrollment open
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cisplatin • Imfinzi (durvalumab) • gemcitabine
22d
New P2 trial
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Sulanda (surufatinib) • Enweida (envafolimab)
22d
Concordance of ctDNA and tissue genomic profiling in advanced biliary tract cancer. (PubMed, J Hepatol)
Among patients with advanced BTC, ctDNA-based genotyping showed acceptable concordance with tissue genomic profiling. Liquid biopsy using ctDNA could be a valuable complement to tissue-based genomic analysis in BTC.
Journal • BRCA Biomarker • Circulating tumor DNA • Metastases • Discordant
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HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MET (MET proto-oncogene, receptor tyrosine kinase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
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BRCA2 mutation • BRCA1 mutation • HER-2 amplification • PIK3CA mutation • IDH1 mutation • MET amplification • FGFR2 mutation • FGFR2 fusion • MET mutation • PIK3CA amplification
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AlphaLiquid® 100
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cisplatin • gemcitabine
22d
New P2 trial • Metastases
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Loqtorzi (toripalimab-tpzi) • oxaliplatin • Sulanda (surufatinib)
24d
Trial completion date • Metastases
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cisplatin • gemcitabine • albumin-bound paclitaxel
24d
New trial • Minimal residual disease
25d
TranStar102: A Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TST001 in Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
P1/2, N=320, Recruiting, Suzhou Transcenta Therapeutics Co., Ltd. | Trial completion date: Nov 2024 --> May 2025 | Trial primary completion date: Aug 2024 --> Feb 2025
Trial completion date • Trial primary completion date • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • CLDN18 (Claudin 18)
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HER-2 negative
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Opdivo (nivolumab) • cisplatin • gemcitabine • paclitaxel • capecitabine • oxaliplatin • osemitamab (TST001)
28d
A Phase 1 Dose-escalation Study of FF-10832 for Treatment of Solid Tumors Including Biliary Tract Cancer (clinicaltrials.gov)
P1, N=90, Active, not recruiting, Fujifilm Pharmaceuticals U.S.A., Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
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liposomal gemcitabine (FF-10832)
28d
Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • NRAS (Neuroblastoma RAS viral oncogene homolog) • RAS (Rat Sarcoma Virus)
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HER-2 amplification • HER-2 expression • KRAS wild-type • BRAF wild-type • NRAS wild-type
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Avastin (bevacizumab) • cisplatin • gemcitabine • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • zanidatamab (ZW25)
28d
New trial • Metastases
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Keytruda (pembrolizumab) • Lenvima (lenvatinib)
28d
Characterization of cell states in biliary tract cancers identifies mechanisms of therapeutic resistance in a phase II trial of DKN-01/nivolumab. (PubMed, medRxiv)
Malignant cell states co-varied with distinct immune cell states, revealing diverse mechanisms of myeloid and T-cell mediated immune suppression, including M2 myeloid and terminally exhausted T cell programs that were induced by DKN-01/nivolumab. Here, we provide the first systematic classification of functionally annotated cell states in biliary tract cancer and provide new insight into resistance mechanisms to an immunotherapy combination that can inform the next generation of trials.
P2 data • Journal
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DKK1 (dickkopf WNT signaling pathway inhibitor 1)
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Opdivo (nivolumab) • sirexatamab (DKN-01)
30d
Expression of the large amino acid transporter SLC7A5/LAT1 on immune cells is enhanced in primary sclerosing cholangitis-associated cholangiocarcinoma and correlates with poor prognosis in cholangiocarcinoma. (PubMed, Hum Pathol)
These results underline the potential use of SLC7A5/LAT1 as a prognostic marker in BTC. Furthermore, the higher frequency of SLC7A5/LAT1 positive immune cells in PSC-BTC compared to sBTC may hint at the potential role of SLC7A5/LAT1 in inflammation-driven carcinogenesis.
Journal • Immune cell
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CD4 (CD4 Molecule) • CD68 (CD68 Molecule) • SLC7A5 (Solute Carrier Family 7 Member 5)
30d
Sensitizing cholangiocarcinoma to chemotherapy by inhibition of the drug-export pump MRP3. (PubMed, Biomed Pharmacother)
Genetic and pharmacological MRP3 inhibition enhances the anti-CCA effect of several drugs, which constitutes a promising strategy to improve the response to chemotherapy in CCA patients.
Journal
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ABCC3 (ATP Binding Cassette Subfamily C Member 3)
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cisplatin • sorafenib • etoposide IV • mitoxantrone
1m
VISIONARY: Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics (clinicaltrials.gov)
P=N/A, N=600, Active, not recruiting, Peking University | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Mar 2025 | Trial primary completion date: Feb 2024 --> Nov 2024
Enrollment closed • Trial completion date • Trial primary completion date • Real-world evidence • Tumor mutational burden • Real-world
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FoundationOne® CDx
1m
SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma (clinicaltrials.gov)
P2, N=34, Suspended, Zhejiang Cancer Hospital | Recruiting --> Suspended
Trial suspension • Surgery
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AiRuiKa (camrelizumab) • Sulanda (surufatinib)
1m
Homologous recombination deficiency (HRD) in biliary carcinomas: clinical significance and correlation with platinum response (DGHO 2024)
In second-line treatment, no difference between an Irinotecan-based regimen and re-exposure to platinum-based agents (12.36 vs 10.13 months; HR 0.92; P=0.85) could be observed (HR 1.45; P=0.35). HRRm BTC patients showed a potential advantage in OS following platinum-based first-line chemotherapy, presumably attributed to enhanced opportunities for targetable co-alterations. Further investigation is needed to delineate HRD in the context of personalizing systemic therapies of BTC.
Clinical
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HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • BAP1 (BRCA1 Associated Protein 1)
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HRD
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FoundationOne® CDx • Archer® FusionPlex® Comprehensive Thyroid & Lung (CTL) Kit • TruSight Tumor 170 Assay
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irinotecan
1m
Clinical and Genomic Characterization of ERBB2-Altered Gallbladder Cancer: Exploring Differences Between an American and a Chilean Cohort. (PubMed, JCO Glob Oncol)
The prevalence of lithiasis seems to be higher in Chilean versus US patients with GBC. A similar prevalence of ERBB2 alterations of overall 14% and better OS suggests that a proportion of them could benefit from human epidermal growth factor receptor type 2-targeted therapies. The smaller cohort of Chile, where the disease prevalence is higher, is a reminder and invitation for the need of more robust next-generation sequencing analyses globally.
Journal • Clinical
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification • HER-2 mutation • HER-2 fusion
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MSK-IMPACT
1m
Pharmacological characteristics and clinical effectiveness of Futibatinib (Lytgobi® Tablets), a covalently-binding, irreversible FGFR1-4 inhibitor (PubMed, Nihon Yakurigaku Zasshi)
Although some typical FGFR inhibitor-related side effects were observed, they were manageable and futibatinib had a good safety profile. Futibatinib is an important drug for biliary tract cancer, which has limited treatment options; its development is underway for other types of cancer, and it is expected to benefit more patients.
Journal
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 fusion • FGFR mutation • FGFR wild-type
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Lytgobi (futibatinib)
1m
Usefulness of multigene liquid biopsy of bile for identifying driver genes of biliary duct cancers. (PubMed, Cancer Sci)
Of the biliary tract cancer cases examined with this method, 13 (54%) and 4 (17%) resulted in positive cancer driver mutation detection in the bile and plasma cfDNAs, respectively. These results suggest that bile is a more reliable source for LB than plasma for multigene panel analyses of biliary tract cancers.
Journal • Liquid biopsy • Biopsy
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LiquidPlex™
1m
Aberrant Expression of Pneumocytic Markers (TTF-1 and Napsin-A) in Biliary Duct and Gallbladder Adenocarcinomas; A Potential Diagnostic Pitfall. (PubMed, Int J Surg Pathol)
We herein report uncommon instances of strong and diffuse expression of these markers in two examples of adenocarcinomas arising from the bile duct and gallbladder. A review of the literature and a summary of similar studies relating to aberrant TTF-1 and Napsin-A expression in biliary tract adenocarcinomas are presented.
Journal
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NKX2-1 (NK2 Homeobox 1) • NAPSA (Napsin A Aspartic Peptidase)
1m
Evolving therapeutic landscape of advanced biliary tract cancer: from chemotherapy to molecular targets. (PubMed, ESMO Open)
In addition to the most common alterations such as isocitrate dehydrogenase 1 or 2 (IDH1/2) mutations, fibroblast growth factor receptor 2 (FGFR2) fusions, and alterations, we will also discuss less frequently encountered alterations such as BRAF V600E mutation and neurotrophic tyrosine kinase receptor gene (NTRK) fusion. We highlight the importance of molecular profiling in guiding therapeutic decisions and emphasize the need for continued research to optimize and expand targeted treatment strategies for this aggressive malignancy.
Review • Journal • IO biomarker • Metastases
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BRAF (B-raf proto-oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • NTRK (Neurotrophic receptor tyrosine kinase)
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BRAF V600E • BRAF V600 • FGFR2 mutation • FGFR2 fusion • IDH mutation + BRAF V600E
1m
Exploring the impact of durvalumab on biliary tract cancer: insights from real-world clinical data. (PubMed, Cancer Immunol Immunother)
This study confirms the phase 3 trial results of durvalumab with platinum and gemcitabine, providing a substantial real-world dataset with detailed molecular characterization. No specific patient subgroup showed a markedly better response to durvalumab based on conventional NGS panels. Further research is needed to explore the link between immunotherapy responses and molecular subgroups.
Clinical data • Retrospective data • Journal • Real-world evidence • Real-world
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HRD (Homologous Recombination Deficiency)
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Imfinzi (durvalumab) • gemcitabine
1m
Exceptional sustained long-term complete response to Tepotinib in a MET-amplified advanced intrahepatic biliary tract cancer failing Durvalumab plus Cisplatin and Gemcitabine. (PubMed, Oncologist)
Tepotinib showed remarkable efficacy in treating MET-amplified intrahepatic cholangiocarcinoma, underscoring the importance of molecular profiling in BTCs and suggesting a potential new therapeutic approach for this rare cancer subtype.
Journal • PD(L)-1 Biomarker • Metastases
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TP53 (Tumor protein P53) • MET (MET proto-oncogene, receptor tyrosine kinase)
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TP53 mutation • MET amplification • MET mutation
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cisplatin • Imfinzi (durvalumab) • gemcitabine • Tepmetko (tepotinib)
1m
Immune cells mediate the causal pathway linking circulating complements to cancer: A Mendelian randomization study. (PubMed, Inflamm Res)
This study revealed the causal relationships between complement components and certain cancers, with five immune cells as potential mediators.
Journal • Immune cell
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IL2RA (Interleukin 2 receptor, alpha) • CD93 (CD93 Molecule) • ENTPD1 (Ectonucleoside Triphosphate Diphosphohydrolase 1) • CEACAM8 (CEA Cell Adhesion Molecule 8) • ISG20 (Interferon Stimulated Exonuclease Gene 20)
1m
New P3 trial
|
5-fluorouracil • capecitabine • irinotecan • leucovorin calcium • gemcitabine oral (D07001)
1m
New P2 trial
|
Ariely (adebrelimab) • HRS-4642
2ms
Trial completion • Metastases
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capecitabine • NGC-capecitabine (PCS6422)
2ms
Molecular profiling in biliary tract cancers: A national practice survey of French platforms (PubMed, Bull Cancer)
This national survey of French genetics platforms shows good performance and compliance with recommendations for molecular analysis. However, many medical, financial and organizational obstacles remain upstream of these platforms.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1)
|
TP53 mutation • BRAF mutation • HER-2 amplification • IDH1 mutation • FGFR2 mutation • FGFR2 fusion
2ms
New trial • Combination therapy
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cisplatin • Imfinzi (durvalumab) • gemcitabine
2ms
The Epidemiology of Biliary Tract Cancer and Associated Prevalence of MDM2 Amplification: A Targeted Literature Review. (PubMed, Target Oncol)
Studies of MDM2 in BTC (N = 19) demonstrated variable frequency of MDM2 amplification according to subtype, with consistently high MDM2 amplification rates in GBC (up to 17.5%), and lower rates in CCA (up to 4.4%). The results from this literature review highlight the geographic heterogeneity of BTC and the need for standardised clinicopathologic assessment and reporting to allow cross-study comparisons.
Review • Journal
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MDM2 (E3 ubiquitin protein ligase)
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MDM2 amplification
2ms
Clinical utility of a comprehensive genomic profiling test for patient with advanced biliary tract cancer. (PubMed, Int J Clin Oncol)
The drug accessibility rate of ICC is high and pemigatinib is effective and well-tolerated in ICC patients harboring FGFR2 gene fusions.
Journal • Metastases
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FGFR2 (Fibroblast growth factor receptor 2)
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FGFR2 fusion
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Pemazyre (pemigatinib)
2ms
Defining the mode of action of cisplatin combined with NUC-1031, a phosphoramidate modification of gemcitabine. (PubMed, Transl Oncol)
The damage associated with NUC-1031 may be potentiated by a second mechanism, via binding the RRM1 subunit of ribonucleotide reductase and perturbing the nucleotide pools; however, this may be mitigated by increased RRM1 expression. The implication of this was investigated in case studies from a Phase I clinical trial to observe whether baseline RRM1 expression in tumour tissue at time of diagnosis correlates with patient survival.
Journal
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RRM1 (Ribonucleotide Reductase Catalytic Subunit M1)
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RRM1 expression
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cisplatin • Acelarin (fosgemcitabine palabenamide)
2ms
Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer (clinicaltrials.gov)
P=N/A, N=14, Active, not recruiting, University of Washington | Recruiting --> Active, not recruiting | N=20 --> 14 | Trial completion date: Jul 2025 --> Jul 2026 | Trial primary completion date: Jul 2024 --> Jul 2025
Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date