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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Sichuan Cancer Hospital and Research Institute
RECRUITING
Chengdu
Contact Information
Primary
Guohui Xu
xgh0913@hotmail.com
+8613708010123
Backup
Xuegang Yang
yanggangxue@163.com
+8613683476844
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 20
Treatments
Experimental: DEB-TACE combined with apatinib and PD-1 antibody
The participants will receive the combined treatment of local therapy (DEB-TACE, oxaliplatin and gemcitabine), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)
Related Therapeutic Areas
Sponsors
Leads: Sichuan Cancer Hospital and Research Institute

This content was sourced from clinicaltrials.gov

Similar Clinical Trials