HAIC Rechallenge in Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety in Patients Resistant to Previous Systemic Chemotherapy

NCT07830147 | Completed DMC

• 1 other identifier: 20261622
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 36 months from the start of HAIC rechallenge treatment.

Secondary Outcomes (3)

• Disease Control Rate (DCR)

  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)

  Up to 36 months from the start of HAIC rechallenge treatment.

• Incidence of Adverse Events

  Throughout the treatment period and up to 30 days after the last HAIC cycle.

Study Arms (1)

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.

Drug: Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge

Interventions

Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge DRUG

Hepatic arterial infusion chemotherapy is delivered via hepatic artery catheter for liver-targeted chemotherapy administration.

HAIC Rechallenge Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (4)

• 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.

  PMID: 37215995 BACKGROUND

• Li 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.

  PMID: 41113056 BACKGROUND

• Maiorano 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.

  PMID: 41259899 BACKGROUND

• Zhao 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.

  PMID: 37864725 BACKGROUND

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Junior Attending Doctor

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 21, 2026
• Study Start: January 1, 2015
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)