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Clinical Trial Summary

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.


Clinical Trial 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 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 Design


Related Conditions & MeSH terms


NCT number NCT04769908
Study type Interventional
Source Sun Yat-sen University
Contact
Status Recruiting
Phase Phase 2
Start date February 23, 2021
Completion date December 1, 2021

See also
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Not yet recruiting NCT06447454 - Combining Chemoradiotherapy With Sintilimab in First-Line ICC
Recruiting NCT03940378 - Treatment of Advanced Intrahepatic Cholangiocarcinoma Phase 3
Withdrawn NCT04682249 - Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC Phase 2