Phase II Study of PDS01ADC with Hepatic Artery Infusion Pump and Systemic Chemotherapy for Liver-Dominant Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, and Adrenocortical Carcinoma

What this Trial Is About

Researchers are investigating a treatment for certain liver-related cancers, including metastatic colorectal cancer, intrahepatic cholangiocarcinoma, and metastatic adrenocortical carcinoma. The study evaluates whether adding the drug PDS01ADC, which activates the immune system, can improve the effects of chemotherapy delivered directly to the liver via a hepatic artery infusion pump HAIP. This Phase II, open-label study aims to determine the objective response rate of this combination treatment in patients receiving standard systemic chemotherapy. Participants will undergo surgery to place a catheter connected to the HAIP, which delivers chemotherapy drugs floxuridine FUDR and dexamethasone directly to the liver every two weeks. PDS01ADC will be given as a subcutaneous injection every four weeks. Standard systemic chemotherapy such as FOLFOX, FOLFIRI, or GemOx will also be administered intravenously every two weeks according to the participants cancer type. Treatment continues until cancer progression or unacceptable side effects occur. Throughout the study, participants will visit the research center twice monthly for assessments, including physical exams, blood tests, and imaging scans every eight weeks. Tumor response, survival rates, and safety will be monitored. After treatment ends, participants have a follow-up visit one month later, then are contacted every six months for up to five years to track long-term outcomes and health.

PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma