Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

Sun Yat-sen University40 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ICC

Interventions

Systemic ChemotherapyDRUG

Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)

LenvatinibDRUG

Lenvatinib, 8mg or 12mg, po, QD

SintilimabDRUG

Sintilimab, IV, 200mg, q3w

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Objective response rate per RECIST

complete response and partial response per RECIST

Time frame: 6 months

Secondary Outcomes

Overall survival

Time frame: 6 months

Progression-free survival

Time frame: 6 months

Number of adverse events

Postoperative adverse events were graded based on CTCAE v4.03

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.