Last updated: July 7, 2021
Sponsor: Shi Ming
Overall Status: Active - Recruiting
Phase
3
Condition
Liver Cancer
Digestive System Neoplasms
Biliary Tract Cancer
Treatment
N/AClinical Study ID
NCT04961970
S035B
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The diagnosis of ICC
- Patients must have at least one tumor lesion that can be accurately measured accordingto mRECIST criteria.
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other curedtreatment.
- Without distant metastasis, but intrahepatic lymph node metastasis is allowed
- The following laboratory parameters: 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 ofnormal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
Exclusion
Exclusion Criteria:
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior tostudy entry.
- Known central nervous system tumors including metastatic brain disease
Study Design
Total Participants: 188
Study Start date:
July 09, 2021
Estimated Completion Date:
July 09, 2025
Connect with a study center
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong 510060
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.