Status:
WITHDRAWN
Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC
Lead Sponsor:
Sun Yat-sen University
Conditions:
ICC
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(first-line treatment from NCCN guideline), our previous s...
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 ≥ 60,000/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 :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04682249
Start Date
December 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