Status:
RECRUITING
DEB-TACE Combined With Apatinib and PD-1 for the Treatment of Intrahepatic Cholangiocarcinoma
Lead Sponsor:
Sichuan Cancer Hospital and Research Institute
Conditions:
Intrahepatic Cholangiocarcinoma
Transarterial Chemoembolization
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 acco...
Detailed Description
This study is a single arm, single center, open label study. It is estimated that 20 patients with intrahepatic cholangiocarcinoma which progressed after treatment with standard first-line chemotherap...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known central nervous system tumors including metastatic brain disease
- Tumor burden≥70%, diffuse liver cancer or tumor is not suitable for mRECIST standard evaluation.
- Received local treatment (ablation therapy), surgery resection and radiotherapy for ICC before the first administration.
- Tumor thrombus of main portal vein, or involving superior mesenteric vein at the same time.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04834674
Start Date
July 1 2024
End Date
April 30 2026
Last Update
June 25 2024
Active Locations (1)
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1
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan, China, 610041