DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma

Launched by SICHUAN CANCER HOSPITAL AND RESEARCH INSTITUTE · Apr 4, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with intrahepatic cholangiocarcinoma (ICC), a type of liver cancer that can be challenging to treat, especially after standard chemotherapy. The trial is exploring the safety and effectiveness of combining a procedure called drug-eluting bead transarterial chemoembolization (DEB-TACE) with two medications: apatinib and a PD-1 antibody. This combination aims to help patients whose cancer has progressed after receiving the usual first-line chemotherapy treatment.

To participate in this trial, patients need to be between 18 and 80 years old and must have a confirmed diagnosis of ICC that is not suitable for surgery or other curative treatments. They should have measurable tumor lesions and need to have shown resistance to standard chemotherapy. Participants can expect regular visits and monitoring throughout the trial, and they will need to provide informed consent to join. This study is currently recruiting participants and aims to offer new hope for those facing advanced stages of this disease.

Gender

ALL

Eligibility criteria

• 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.