Systemic Chemotherapy, Apatinib Plus Sintilimab for Metastasis ICC

ICC Clinical Trial

Official title: Systemic Chemotherapy Based on Oxaliplatin and 5-fluorouracil, Apatinib Plus Sintilimab for Metastasis ICC: a Single Arm Prospective Study

Status Withdrawn

Clinical Trial 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 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 metastatic ICC.

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 ), apatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody). Our study were designed to verify the better method of survival for metastatic ICC. ;

Related Conditions & MeSH terms

• ICC
• Neoplasm Metastasis

• NCT number: NCT04682249
• Study type: Interventional
• Source: Sun Yat-sen University
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 1, 2020
• Completion date: February 1, 2021