Biliary Tract CancerNCT07830147
HAIC Rechallenge in Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety in Patients Resistant to Previous Systemic Chemotherapy
An observational study of Biliary Tract Cancer, run by West China Hospital at 1 site in China.
Trial summary
Plain Language Summary This study uses hepatic arterial infusion chemotherapy (HAIC) rechallenge for patients with biliary tract cancer or colorectal cancer liver metastases whose disease has progressed after previous systemic chemotherapy. We aimed to evaluate the treatment's effectiveness and safety. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge
- Type of treatment
- Injection or infusion
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Pathologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) or colorectal cancer with liver metastases.
- 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.
- Interval between the last cycle of prior systemic chemotherapy and initiation of HAIC rechallenge is at least 1 month.
- At least one measurable target lesion in the liver per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
- Adequate major organ function to meet the requirements for HAIC treatment.
- Voluntarily signed informed consent form.
- -
Who cannot join
- Extensive extrahepatic metastases (except for isolated, locally manageable pulmonary or lymph node metastases).
- Contraindications to HAIC, including severe coagulopathy, complete portal vein main trunk tumor thrombus, or Child-Pugh class C liver function.
- Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment.
- Concomitant other uncontrolled malignancies.
- Pregnant or breastfeeding women.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Arterial Infusion Chemotherapy Rechallenge for Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety Analysis in Patients With Prior Resistance to Systemic Chemotherapy
Plain Language Summary This study uses hepatic arterial infusion chemotherapy (HAIC) rechallenge for patients with biliary tract cancer or colorectal cancer liver metastases whose disease has progressed after previous systemic chemotherapy. We aimed to evaluate the treatment's effectiveness and safety. The findings may help patients, family members and healthcare providers understand the benefits and risks of HAIC rechallenge for this patient group.
- Conditions
- Biliary Tract Cancer
- Being tested
- Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic Arterial Infusion Chemotherapy (HAIC) RechallengeDrug
Hepatic arterial infusion chemotherapy is delivered via hepatic artery catheter for liver-targeted chemotherapy administration.
| Study group | Role | What they receive |
|---|---|---|
| HAIC Rechallenge Cohort | Patients with pathologically confirmed biliary tract cancer or colorectal cancer liver metastases who developed disease progression after prior systemic chemotherapy and received hepatic arterial infusion chemotherapy (HAIC) rechallenge. This retrospective observational study evaluates the efficacy and safety of HAIC rechallenge in this patient population. Receives: Drug: Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate defined as the percentage of patients with complete response (CR) or partial response (PR) assessed according to RECIST version 1.1. Tumor assessments were performed by contrast-enhanced CT/MRI.
Measured: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.
Progression-Free Survival (PFS)
Time from the start of HAIC rechallenge to disease progression (RECIST 1.1) or death from any cause, whichever occurs first.
Measured: Up to 36 months from the start of HAIC rechallenge treatment.
Secondary outcomes (3)
Disease Control Rate (DCR)
Disease control rate defined as the percentage of patients with CR, PR or stable disease (SD) per RECIST 1.1, evaluated by contrast-enhanced CT/MRI.
Measured: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.
Overall Survival (OS)
Time from the start of HAIC rechallenge to death from any cause. Patients alive at last follow-up will be censored.
Measured: Up to 36 months from the start of HAIC rechallenge treatment.
Incidence of Adverse Events
The incidence and severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Throughout the treatment period and up to 30 days after the last HAIC cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startJan 2015
- Primary completionDec 2025
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dai Ruihong, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830147
- Sponsor's protocol ID
- 20261622
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared, because of patient privacy protection and local hospital data management policy.
Publications
Hu H, Wang K, Jia R, Zeng ZX, Zhu M, Deng YL, Xiong ZJ, Tang JN, Xie H, Wang Y, Zhang P, Zhou J. Current Status in Rechallenge of Immunotherapy. Int J Biol Sci. 2023 May 7;19(8):2428-2442. doi: 10.7150/ijbs.82776. eCollection 2023.
PubMed 37215995Li P, Yang H, Xu H. Re-challenge with immune checkpoint inhibitors as second-line treatment in advanced esophageal squamous cell carcinoma: a real-world multicenter retrospective study. Am J Transl Res. 2025 Sep 15;17(9):7180-7194. doi: 10.62347/WUAN7448. eCollection 2025.
PubMed 41113056Maiorano BA, Cigliola A, Tateo V, Mercinelli C, Pastorino GL, Dizman N, Ebrahimi H, Pal SK, Gupta S, Grivas P, Kamat AM, Spiess PE, Agarwal N, Necchi A. Outcomes of immune checkpoint inhibitor rechallenge in advanced urothelial carcinoma: results from a global real-world evidence study. ESMO Open. 2025 Dec;10(12):105862. doi: 10.1016/j.esmoop.2025.105862. Epub 2025 Nov 18.
PubMed 41259899Zhao M, Guo Z, Zou YH, Li X, Yan ZP, Chen MS, Fan WJ, Li HL, Yang JJ, Chen XM, Xu LF, Zhang YW, Zhu KS, Sun JH, Li JP, Jin Y, Yu HP, Duan F, Xiong B, Yin GW, Lin HL, Ma YL, Wang HM, Gu SZ, Si TG, Wang XD, Zhao C, Yu WC, Guo JH, Zhai J, Huang YH, Wang WY, Lin HF, Gu YK, Chen JZ, Wang JP, Zhang YM, Yi JZ, Lyu N. Arterial chemotherapy for hepatocellular carcinoma in China: consensus recommendations. Hepatol Int. 2024 Feb;18(1):4-31. doi: 10.1007/s12072-023-10599-6. Epub 2023 Oct 21.
PubMed 37864725
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Arterial Infusion Chemotherapy Rechallenge for Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety Analysis in Patients With Prior Resistance to Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT07830147
- Acronym / sponsor ID
- 20261622
- Conditions
- Biliary Tract Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2025 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Plain Language Summary This study uses hepatic arterial infusion chemotherapy (HAIC) rechallenge for patients with biliary tract cancer or colorectal cancer liver metastases whose disease has progressed after previous systemic chemotherapy. We aimed to evaluate the treatment's effectiveness and safety. The findings may help patients, family members and healthcare providers understand the benefits and risks of HAIC rechallenge for this patient group.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HAIC Rechallenge Cohort | – | Drug: Hepatic Arterial Infusion Chemotherapy (HAIC) RechallengePatients with pathologically confirmed biliary tract cancer or colorectal cancer liver metastases who developed disease progression after prior systemic chemotherapy and received hepatic arterial infusion chemotherapy (HAIC) rechallenge. This retrospective observational study evaluates the efficacy and safety of HAIC rechallenge in this patient population. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Pathologically confirmed biliary tract cancer (including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, distal cholangiocarcinoma) or colorectal cancer with liver metastases.
- 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.
- Interval between the last cycle of prior systemic chemotherapy and initiation of HAIC rechallenge is at least 1 month.
- At least one measurable target lesion in the liver per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2.
Key exclusion criteria (6 listed)
- Extensive extrahepatic metastases (except for isolated, locally manageable pulmonary or lymph node metastases).
- Contraindications to HAIC, including severe coagulopathy, complete portal vein main trunk tumor thrombus, or Child-Pugh class C liver function.
- Prior local therapies (such as ablation or radiotherapy) before HAIC rechallenge that would interfere with target lesion assessment.
- Concomitant other uncontrolled malignancies.
- Pregnant or breastfeeding women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic Arterial Infusion Chemotherapy (HAIC) RechallengeHepatic arterial infusion chemotherapy is delivered via hepatic artery catheter for liver-targeted chemotherapy administration. | Drug | HAIC Rechallenge Cohort |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.
Objective response rate defined as the percentage of patients with complete response (CR) or partial response (PR) assessed according to RECIST version 1.1. Tumor assessments were performed by contrast-enhanced CT/MRI.
Progression-Free Survival (PFS)
Time frame: Up to 36 months from the start of HAIC rechallenge treatment.
Time from the start of HAIC rechallenge to disease progression (RECIST 1.1) or death from any cause, whichever occurs first.
3 secondary outcomes
Disease Control Rate (DCR)
Time frame: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.
Overall Survival (OS)
Time frame: Up to 36 months from the start of HAIC rechallenge treatment.
Incidence of Adverse Events
Time frame: Throughout the treatment period and up to 30 days after the last HAIC cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 37215995Hu H, Wang K, Jia R, Zeng ZX, Zhu M, Deng YL, Xiong ZJ, Tang JN, Xie H, Wang Y, Zhang P, Zhou J. Current Status in Rechallenge of Immunotherapy. Int J Biol Sci. 2023 May 7;19(8):2428-2442. doi: 10.7150/ijbs.82776. eCollection 2023.
- Background: PubMed 41113056Li P, Yang H, Xu H. Re-challenge with immune checkpoint inhibitors as second-line treatment in advanced esophageal squamous cell carcinoma: a real-world multicenter retrospective study. Am J Transl Res. 2025 Sep 15;17(9):7180-7194. doi: 10.62347/WUAN7448. eCollection 2025.
- Background: PubMed 41259899Maiorano BA, Cigliola A, Tateo V, Mercinelli C, Pastorino GL, Dizman N, Ebrahimi H, Pal SK, Gupta S, Grivas P, Kamat AM, Spiess PE, Agarwal N, Necchi A. Outcomes of immune checkpoint inhibitor rechallenge in advanced urothelial carcinoma: results from a global real-world evidence study. ESMO Open. 2025 Dec;10(12):105862. doi: 10.1016/j.esmoop.2025.105862. Epub 2025 Nov 18.
- Background: PubMed 37864725Zhao M, Guo Z, Zou YH, Li X, Yan ZP, Chen MS, Fan WJ, Li HL, Yang JJ, Chen XM, Xu LF, Zhang YW, Zhu KS, Sun JH, Li JP, Jin Y, Yu HP, Duan F, Xiong B, Yin GW, Lin HL, Ma YL, Wang HM, Gu SZ, Si TG, Wang XD, Zhao C, Yu WC, Guo JH, Zhai J, Huang YH, Wang WY, Lin HF, Gu YK, Chen JZ, Wang JP, Zhang YM, Yi JZ, Lyu N. Arterial chemotherapy for hepatocellular carcinoma in China: consensus recommendations. Hepatol Int. 2024 Feb;18(1):4-31. doi: 10.1007/s12072-023-10599-6. Epub 2023 Oct 21.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared, because of patient privacy protection and local hospital data management policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 weeks from the start of HAIC rechallenge treatment; tumor imaging assessments at baseline and every 6-8 weeks thereafter until 24 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830147, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.