Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Study Overview
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Brief Summary
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This study were designed to verify the better method of survival for ICC with distant metastasis. Since the traditional method for ICC with distant metastasis. was GEMOX(first-line treatment from NCCN guideline), our previous study found similar results from FOLFOX (second-line treatment from NCCN guideline) compared with GEMOX. Our current study were conducted for further investigation to verify the better method for with distant metastasis.

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 FOLFOX (Systemic Chemotheray based on Oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with 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 FOLFOX (Systemic Chemotheray based on Oxaliplatin#5-fluorouracil ), lenvatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody).

Official Title
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Systemic Chemotherapy With Oxaliplatin and 5-fluorouracil, Lenvatinib Plus Sintilimab for With Distant Metastasis: a Single Arm Prospective Study

Conditions
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ICC

Intervention / Treatment
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* Drug: Systemic Chemotherapy
* Drug: Lenvatinib
* Drug: Sintilimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The diagnosis of Intrahepatic CholangioCarcinoma (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 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: Systemic Chemotherapy, Lenvatinib Plus Sintilimab<br> | Drug: Systemic Chemotherapy<br>* Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)<br>Drug: Lenvatinib<br>* Lenvatinib, 8mg or 12mg, po, QD<br>Drug: Sintilimab<br>* Sintilimab, IV, 200mg, q3w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate per RECIST | complete response and partial response per RECIST | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 6 months | 
| Progression-free survival |  | 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, Lenvatinib, Sintilimab, Systemic Chemotheray