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Second try: pumping chemo straight into the liver for tumors that outsmarted standard treatment

NCT ID NCT07830147

NEW Disease control Sponsor: West China Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether delivering chemotherapy directly into the liver through a catheter in the hepatic artery can help people with biliary tract cancer or colorectal cancer that has spread to the liver and stopped responding to standard intravenous chemotherapy. The study enrolls about 72 adults who have already received at least two cycles of systemic chemotherapy and whose cancer progressed despite that treatment. The main goals are to measure how many tumors shrink and how long patients live without their cancer getting worse, while tracking side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hepatic arterial infusion chemotherapy, a technique that delivers chemotherapy drugs straight into the liver through a catheter in the hepatic artery
What this could lead to
If it works, this approach could offer a liver-directed option for people whose cancer kept growing after standard chemotherapy, possibly shrinking liver tumors or delaying further spread.
What could go wrong
The study is small and early, so results may not hold up in larger groups. Pumping chemotherapy directly into the liver can cause liver damage, bleeding, infection, or blocked blood vessels, and the treatment may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

72 people

The number who actually took part.

Started

Jan 2015

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients aged ≥18 years with pathologically confirmed biliary tract cancer or colorectal cancer liver metastases, who developed resistance after prior systemic chemotherapy and received HAIC rechallenge. Eligible patients had measurable hepatic lesions and adequate organ function for HAIC treatment.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria:Inclusion Criteria: 1. Pathologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) or colorectal cancer with liver metastases. 2. Received at least 2 cycles of prior systemic chemotherapy, with best response of stable disease (SD) followed by progression, or direct progressive disease (PD), indicating resistance to prior systemic chemotherapy. 3. Interval between the last cycle of prior systemic chemotherapy and initiation of HAIC rechallenge is at least 1 month. 4. At least one measurable target lesion in the liver per RECIST 1.1 criteria. 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2. 6. Adequate major organ function to meet the requirements for HAIC treatment. 7. Voluntarily signed informed consent form. \- Exclusion Criteria:Exclusion Criteria: 1. Extensive extrahepatic metastases (except for isolated, locally manageable pulmonary or lymph node metastases). 2. Contraindications to HAIC, including severe coagulopathy, complete portal vein main trunk tumor thrombus, or Child-Pugh class C liver function. 3. Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment. 4. Concomitant other uncontrolled malignancies. 5. Pregnant or breastfeeding women. \-

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer

Contacts and locations

Locations

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

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