Phase 3 study for people with Liver Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 3
Sponsor Taiho Pharmaceutical Co., Ltd.
Registry number NCT07710885
Started 24 June 2026 Today 16 October 2026 Estimated completion 30 April 2030

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Research Site Brisbane Australia Not yet recruiting
Research Site Melbourne Australia Not yet recruiting
Research Site Perth Australia Not yet recruiting
Research Site Sydney Australia Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 784

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

1. Has histologically confirmed unresectable or advanced biliary tract (i.e. intrahepatic bile duct, extrahepatic bile duct, or gallbladder) cancer that is adenocarcinoma or adenosquamous carcinoma;

2. Has no history of prior treatment for locally advanced or metastatic Biliary Tract Cancer (BTC);

* Adjuvant or neoadjuvant chemotherapy is not considered as prior treatment if more than 6 months have passed since its completion.

3. Has radiographically measurable disease per RECIST v1.1.

4. Has a tumor tissue sample available for biomarker analysis in a quantity sufficient.

5. Has an ECOG PS of 0 or 1 before administration of study treatment; Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria.

Exclusion Criteria:

1. History and/or current evidence of clinically significant nontumor-related alteration of calcium-phosphorus homeostasis;

2. History and/or current evidence of clinically significant retinal disorder confirmed by retinal examination;

3. Has prior Fibroblast Growth Factor Receptor (FGFR)-directed therapy including futibatinib

4. Has prior treatment with an anti-Programmed Death Ligand 1 (PD-L1), anti-Programmed Cell Death Protein 1 (PD-1), anti-Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4), anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT), or other immune checkpoint inhibitor (ICI) or agonist as monotherapy or in combination.

Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Dates on the record

Started 24 June 2026
Estimated completion 30 April 2030
Registry last updated 17 July 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 17 July 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.