Systemic Chemotherapy Plus PD-1 for Metastasis ICC

Study Overview
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Brief Summary
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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 found better results from Folfirinox over GEMOX. Our current study were conducted for further investigation to verify the better method for metastatic ICC.

Detailed Description
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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 recommended from NCCN guideline was GEMOX(Systemic Chemotheray) and clinical trials. Our previous study has demonstrate Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) has a survival and tumor response advantage of GEMOX. Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with Folfirinox(Systemic Chemotheray based on Oxaliplatin，5-fluorouracil and Irinotecan) plus PD1(Sintilimab). The progression free survival and overall survival were our primary and secondary endpoint. Our study were designed to verify the better method of survival for metastatic ICC.

Official Title
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Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil Plus PD-1 for Metastasis ICC-single Arm Prospective Study

Conditions
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ICC, Metastatic Cancer

Intervention / Treatment
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* Drug: Folfirinox
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Folfirinox plus PD1<br>Patients treated with systemic chemotherapy(regimen: Folfirinox) plus PD1 | Drug: Folfirinox<br>* Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)<br>Drug: Sintilimab<br>* Sintilimab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival rate of 6 months | Ratio of patients observed progression of tumor at 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Time from enrollment to death for any reason. | 6 months | 
| Number of adverse events | Postoperative adverse events were graded based on CTCAE v4.03 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICC, metastasis