NCT04834674CompletedPhase 2
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 · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 4 Apr 2021
- Start date
- 1 Jul 2024
- Primary completion date
- 5 Apr 2026
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT04834674
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- From 1 Jul 2024 to the primary completion date, 5 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
Other illness
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Known central nervous system tumors including metastatic brain disease
- Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
Other
- Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
Who the study is looking for
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
- Stand first-line chemotherapy resistance.
- Performance status (PS) ≤ 2 (ECOG scale).
- Child Pugh score ≤ 7.
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- 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
- Sign the written informed consent, and be able to follow the visit and relevant procedures specified in the plan
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sichuan Cancer Hospital and Research Institute Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.