Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs

Summary

This is a single-arm, phase I/II trial in biliary tract cancer (BTC) patients. The purpose of this trial is to evaluate the safety and effect of PD-1 inhibitor in combination with gemcitabine/cisplatin chemotherapy in patients with advanced unresectable or metastatic BTCs. The primary objective: 6-month progression free survival (PFS). The second objectives: objective clinical response(according to RECIST version 1.1), safety, symptom control and quality of life (QoL) (according to EORTC QoL C30 and BIL 21), overall survival. The exploratory objectives: assessment of immunological response (cytokines, lymphocyte phenotype, immunoglobulins), and evaluation of pathological, immunological and clinical predictive factors for response/toxicity.

Timeline

Start

2017-05-01

Primary completion

2018-10

Completion

2019-10

Publications

• Feng K, Liu Y, Zhao Y, Yang Q, Dong L, Liu J, Li X, Zhao Z, Mei Q, Han W. Efficacy and biomarker analysis of nivolumab plus gemcitabine and cisplatin in patients with unresectable or metastatic biliary tract cancers: results from a phase II study. J Immunother Cancer. 2020 Jun;8(1):e000367. doi: 10.1136/jitc-2019-000367.

Drugs

Indications