Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer

Conditions

• Advanced Biliary Tract Cancer
• Extrahepatic Cholangiocarcinoma
• Gallbladder Carcinoma
• Intrahepatic Cholangiocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Irinotecan Liposome Injection — DRUG
  Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL
• SG001 — DRUG
  Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL
• Fluorouracil — DRUG
  5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle
• Leucovorin — DRUG
  Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle

Study Details

This study is an open-label, phase II study of irinotecan liposome injection in patients with advanced biliary tract cancer. The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of irinotecan liposome injection in patients with advanced biliary tract cancer.

Key Dates

Start date

Sep 1, 2021

Status verified

Jun 2024

Primary completion

Jan 16, 2023

Completion

Jan 16, 2023

Study Design

Enrollment

17 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Irinotecan Liposome Injection + 5-FU/LV
  The patients in cohort 1 will receive irinotecan liposome injection combined with 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or termination of the study for other reasons.
• Experimental: Cohort 2: Irinotecan Liposome Injection + SG001 + 5-Fu/LV
  The patients in cohort 1 will receive irinotecan liposome injection combined with SG001, 5-Fluorouracil (5-FU) and Leucovorin (LV) intravenously on days 1 of every 14-day cycle until disease progression or unacceptable toxicity, or until 24 months is reached, or the study is terminated for other reasons.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to six months after the last patient's first administration ]

Related Studies

• Regional or Extend LymphAdenectomy During Resection of Intrahepatic Cholangiocarcinoma
  Recruiting · Second Affiliated Hospital, School of Medicine, Zhejiang University · Baltimore, Maryland
• Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery
  PHASE2 · Recruiting · Memorial Sloan Kettering Cancer Center · Bethesda, Maryland
• An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma
  PHASE2 · Recruiting · Virogin Biotech Canada Ltd · Phoenix, Arizona
• The Purpose of This Research Study is to See if Combining Gemcitabine, Cisplatin and Durvalumab Chemotherapy Treatments With a Direct Tumor Therapy Yittrium-90 (Y-90) Will Work Better Together to Shrink Tumors and Control Cancer
  PHASE2 · Recruiting · Inova Health Care Services · Fairfax, Virginia