Status:
WITHDRAWN
Systemic Chemotherapy Plus PD-1 for Metastasis ICC
Lead Sponsor:
Sun Yat-sen University
Conditions:
ICC
Metastatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study were designed to verify the better method of survival for metastatic ICC. Since the traditional method for metastatic ICC was GEMOX(recommended from NCCN guideline), our previous study fou...
Detailed Description
ICC(Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommend...
Eligibility Criteria
Inclusion
- The diagnosis of ICC
- With distant metastasis
- Patients must have at least one tumor lesion that can be accurately measured according to 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 cured treatment
- 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 of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3
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.
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04398927
Start Date
May 1 2020
End Date
February 1 2021
Last Update
February 4 2021
Active Locations (1)
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1
Cancer Center Sun Yat-sen University
Guangzhou, Guangdong, China, 510060