Clinical trial · Observational
HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Intrahepatic cholangiocarcinoma (ICC) is associated with poor prognosis. This study aims to explore the efficacy and safety FOLFOX-HAIC in combination with targeted therapy and/or PD-1 inhibitors for patients with initially unresectable ICC, as well as its role in conversion therapy. Data were retrospectively reviewed for patients with locally advanced unresectable ICC treated with FOLFOX-HAIC combined with targeted therapy and/or PD-1 inhibitors. The treatment efficacy and safety were evaluated.
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 |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- FOLFOX-HAIC plus targeted therapy and/or PD-1 inhibitors
- description
- FOLFOX-HAIC as the following dosage: 130 mg/m2 oxaliplatin infusion for 2 hours; 400 mg/m2 of leucovorin infusion for 2 hours; and 400 mg/ m2 of 5-FU bolus and 1200 of mg/m2 continuous infusion of 5-FU for 23 hours. Patients received targeted therapy, three different targeted therapy were applied including: 1. lenvatinib 2. sorafenib; 3. apatinib. A portion of patients received PD-1 inhibitor administered intravenously every three weeks.
- interventionNames
- Procedure: hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX)
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- 12 months
- description
- The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients were initially diagnosed without any previous oncological treatment. 2. The tumor was assessed as unresectable by two hepatobiliary surgeons (BL and YY, with more than 15 years of experience). Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein. 3. At least one assessable intrahepatic lesion. 4. classified as Child-Pugh Grade A. 5. ECOG PS score 0-1. 6. baseline blood tests meet the following criteria: leukocytes ≥3.0×10\^9/L; neutrophils ≥1.5×10\^9/L; platelets ≥75×10\^9/L; hemoglobin ≥ 80g/L; serum ALT or AST ≤ 3 times of upper limit of normal (ULN); serum creatinine ≤1.5 x ULN; INR ≤ 1.5, or prothrombin time ≤ ULN + 4 seconds; albumin ≥ 30 g/L; total bilirubin ≤ 3 x ULN. Exclusion Criteria: 1. severe underlying cardiac, pulmonary, or renal diseases. 2. a second primary malignancy. 3. prior history of organ transplantation.
References
Publications (0)
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