Neoplasms

All Conditions

Rare Diseases

Cholangiocarcinoma

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Bile Duct Cancer

Intrahepatic Cholangiocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Lenvatinib

Cisplatin

Protein Kinase Inhibitors

Enzyme Inhibitors

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).

GC combined Lenvatinib

Xiaoyong Huang, MD

Guo-ming Shi, MD

Huang xiaoyong, MD

Xiaoyong Huang, MD & PhD

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

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.

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

Objective response rate of advanced and unresectable intrahepatic cholangiocarcinoma

From the beginning date of combined therapy to the date of death

From the beginning date of combined therapy to disease progression or death, whichever occurs first.

Shanghai Zhongshan Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma	NCT04527679	Cholangiocarcin...	GC combined Len...	18 Years - 75 Years	Shanghai Zhongshan Hospital
Cisplatin and Gemcitabine Chemotherapy and Lenvatinib for Patients With Unresectable Intrahepatic Cholangiocarcinoma	NCT04527679	Cholangiocarcin...	GC combined Len...	18 Years - 75 Years	Shanghai Zhongshan Hospital

Spots Global Cancer Trial Database for gc combined lenvatinib