NCT04398927

Systemic Chemotherapy Plus PD-1 for Metastasis ICC

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• ICC
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Folfirinox	Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)
DRUG	Sintilimab	Sintilimab

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-01-01
• Completion: 2021-02-01
• First posted: 2020-05-22
• Last updated: 2021-02-04

Locations

1 site across 1 country: China