Clinical trial · Observational
HAIC Rechallenge in Biliary Tract Cancer and Colorectal Cancer Liver Metastases: Efficacy and Safety in Patients Resistant to Previous Systemic Chemotherapy
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
NCT07830147CI-TRIAL-00126502completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HAIC Rechallenge Cohort
- description
- 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.
- interventionNames
- Drug: Hepatic Arterial Infusion Chemotherapy (HAIC) Rechallenge
Primary outcomes (2)
- measure
- Objective Response Rate (ORR)
- timeFrame
- 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.
- description
- 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.
- measure
- Progression-Free Survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (4)
- BACKGROUNDHu 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
- BACKGROUNDLi 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
- BACKGROUNDMaiorano 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
- BACKGROUNDZhao 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