OncoMatch/Clinical Trials/NCT04834674
DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma
Is NCT04834674 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies DEB-TACE combined with apatinib and PD-1 antibody for intrahepatic cholangiocarcinoma.
Treatment: DEB-TACE combined with apatinib and PD-1 antibody — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: first-line chemotherapy
Stand first-line chemotherapy resistance.
Cannot have received: local treatment (ablation therapy), surgery resection and radiotherapy for ICC
Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
Lab requirements
Blood counts
Platelet count ≥ 50,000/μL; Hemoglobin ≥ 8.5 g/dL; Absolute neutrophil count (ANC) >1,500/mm3; INR ≤ 1.5 or PT/APTT within normal limits
Kidney function
Serum creatinine ≤ 1.5 x upper limit of normal
Liver function
Total bilirubin ≤ 30mmol/L; Serum albumin ≥ 32 g/L; ASL and AST ≤ 6 x upper limit of normal
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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