NCT04527679

Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma

Combined Therapy Using Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma, a Single-arm Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We aim to explore the effects and safety of GC (Cisplatin and gemcitabine) chemotherapy combined with Lenvatinib as first-line therapy in advanced or unresectable intrahepatic cholangiocarcinoma

Detailed description

For advanced intrahepatic cholangiocarcinoma (ICC) that cannot be surgically removed or accompanied by metastasis, the NCCN guidelines (NCCN guidelines hepatobiliary cancer, 2019) recommend that the current treatment options are limited, mainly recommending gemcitabine combined with platinum based antitumor drugs (cisplatin, oxaliplatin, etc.) chemotherapy as first-line treatment. Adding targeted drugs can enhance the anti-tumor effect. GC chemotherapy (Cisplatin + gemcitabine) has been used in the treatment of advanced intrahepatic cholangiocarcinoma, but the efficacy is still not satisfactory. Lenvatinib is a small-molecule multikinase inhibitor that is currently approved for first-line treatment of advanced hepatocellular carcinoma. Lenvatinib combined with chemotherapy may have a better effect than single use for advanced ICC. At present, lenvatinib combined with GC chemotherapy in the first-line treatment of advanced ICC has not been reported.

Conditions

• Cholangiocarcinoma, Intrahepatic

Interventions

Type	Name	Description
DRUG	GC combined Lenvatinib	1. GC chemotherapy D1 Cisplatin 25mg/m2+ gemcitabine 1g/m2, D8 gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 8 courses. 2. Lenvatinib (\<60kg: 8mg /d; ≥60kg, 12mg).

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-06-01
• Completion: 2022-12-01
• First posted: 2020-08-26
• Last updated: 2020-08-26

Locations

1 site across 1 country: China