Clinical trial · Interventional
DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma
Drug-eluting Beads Transarterial Chemoembolization Combined With Apatinib and PD-1 Antibody for the Treatment of Intrahepatic Cholangiocarcinoma That Has Progressed After Standard First-line Chemotherapy
- 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 a malignant tumor of biliary epithelial cells that originates from the branches of the intrahepatic bile duct at the second level and above. Its incidence accounts for about 15%-20% of primary liver malignancies, showing a gradually increasing trend. Surgical resection is currently the main method for the treatment of ICC. However, most (60% -70%) patients are diagnosed at the advanced stage. Gemcitabine plus cisplatin is the standard first-line incurable resection recommended in international and domestic guidelines. There is not a standard second-line treatment that has progressed after standard first-line chemotherapy. The clinical benefits of immune therapies for HCC are emerging. Early clinical data already show the safety of immune checkpoint inhibition. This study is to analyze the safety and efficacy of drug-eluting beads transarterial chemoembolization combined with apatinib and carrelizumab injection in the treatment of ICC that has progressed after standard first-line chemotherapy. Patients who were aged 18 to 80 years with a histological or cytological diagnosis of ICC，locally advanced or multiple liver metastases, including progression after gemcitabine chemotherapy, will be enrolled in this trial.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Apatinib | — | UNRESOLVED | — |
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| PD-1 Antibody | — | UNRESOLVED | — |
| Transarterial Chemoembolization | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEB-TACE combined with apatinib and PD-1 antibody | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DEB-TACE combined with apatinib and PD-1 antibody
- description
- The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)
- interventionNames
- Combination Product: DEB-TACE combined with apatinib and PD-1 antibody
Primary outcomes (2)
- measure
- objective response rate (ORR)
- timeFrame
- Change from baseline tumor volume at 6 months
- description
- The proportion of patients whose tumor volume reduction reaches the predetermined value and can maintain the minimum time limit. It is the sum of the proportion of complete response (CR) and partial response(PR). That is, ORR = CR + PR
- measure
- progression free survival (PFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. The diagnosis of ICC 2. Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria. 3. Stand first-line chemotherapy resistance. 4. Performance status (PS) ≤ 2 (ECOG scale). 5. Child Pugh score ≤ 7. 6. Not amendable to surgical resection ,local ablative therapy and any other cured treatment. 7. Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3 8. Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan Exclusion Criteria: 1. Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 2. Known history of HIV 3. History of organ allograft 4. Known or suspected allergy to the investigational agents or any agent given in association with this trial. 5. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 6. Evidence of bleeding diathesis. 7. Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. 8. Known central nervous system tumors including metastatic brain disease 9. Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation. 10. Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration. 11. Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
References
Publications (0)
Data not yet available