A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer

Summary

Participation Requirements

Description

This study includes two phases,the first phase is the dose exploration, 6 subjects were first included at the initial dose to confirm the dose safety. If the toxicity is not tolerated, the dose of the chemotherapeutic agent will be reduced depending on the toxicity(including hematological toxicity a...

This study includes two phases,the first phase is the dose exploration, 6 subjects were first included at the initial dose to confirm the dose safety. If the toxicity is not tolerated, the dose of the chemotherapeutic agent will be reduced depending on the toxicity(including hematological toxicity and non-hematological toxicity) for further exploration. If it can be tolerated, the recommended dose is determined and expanded on this dose. the second phase is the dose expansion, 4 subjects will be enrolled to further observe the safety and efficacy. The DLT(Dose limited toxicity) observation period is set as the first course of treatment(3 weeks). The end point is that the patient has been taking the drug for 16 cycles or 1 year, or the patient dies or develops intolerable toxicity or confirmed disease recurrence or distant metastasis or withdrawal of informed consent.

Tracking Information