NCT04769908

Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• 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 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

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).

Conditions

• ICC

Interventions

Type	Name	Description
DRUG	Systemic Chemotherapy	Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)
DRUG	Lenvatinib	Lenvatinib, 8mg or 12mg, po, QD
DRUG	Sintilimab	Sintilimab, IV, 200mg, q3w

Timeline

• Start date: 2021-02-23
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-02-25
• Last updated: 2021-02-25

Locations

1 site across 1 country: China