Skip to main content
OpenTrials
Completed

NCT Number: NCT05489692

HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma

Intrahepatic cholangiocarcinoma (ICC) is associated with poor prognosis. This study aims to explore the efficacy and safety FOLFOX-HAIC in combination with targeted therapy and/or PD-1 inhibitors for patients with initially unresectable ICC, as well as its role in conversion therapy. Data were retrospectively reviewed for patients with locally advanced unresectable ICC treated with FOLFOX-HAIC combined with targeted therapy and/or PD-1 inhibitors. The treatment efficacy and safety were evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were initially diagnosed without any previous oncological treatment.
  • The tumor was assessed as unresectable by two hepatobiliary surgeons (BL and YY, with more than 15 years of experience). Any of the following conditions: (1) Residual liver volume less than 30-40%; (2) Not possible for R0 radical resection; (3) Tumor invades the portal vein, hepatic artery and bile duct, and the normal residual liver cannot be guaranteed blood supply and bile drainage; the tumor involves the hepatic veins and cannot preserve at least one vein.
  • At least one assessable intrahepatic lesion.
  • classified as Child-Pugh Grade A.
  • ECOG PS score 0-1.
  • baseline blood tests meet the following criteria: leukocytes ≥3.0×10^9/L; neutrophils ≥1.5×10^9/L; platelets ≥75×10^9/L; hemoglobin ≥ 80g/L; serum ALT or AST ≤ 3 times of upper limit of normal (ULN); serum creatinine ≤1.5 x ULN; INR ≤ 1.5, or prothrombin time ≤ ULN + 4 seconds; albumin ≥ 30 g/L; total bilirubin ≤ 3 x ULN.

Exclusion criteria

  • severe underlying cardiac, pulmonary, or renal diseases.
  • a second primary malignancy.
  • prior history of organ transplantation.

Treatment and study plan

hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX)

Procedure

FOLFOX-HAIC as the following dosage: 130 mg/m2 oxaliplatin infusion for 2 hours; 400 mg/m2 of leucovorin infusion for 2 hours; and 400 mg/ m2 of 5-FU bolus and 1200 of mg/m2 continuous infusion of 5-FU for 23 hours.

Patients received targeted therapy, three different targeted therapy were applied including: 1. lenvatinib 2. sorafenib; 3. apatinib. A portion of patients received PD-1 inhibitor administered intravenously every three weeks.

Other names: targeted therapy, PD-1 inhibitors

Primary outcomes

  1. Tumor Response

    Time frame: 12 months

    The tumor responses were evaluated by measuring the longest diameter of target lesions according to response evaluation criteria in solid tumors (RECIST) version 1.1

Secondary outcomes

  1. Overall survival

    Time frame: 24 months

    Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.

  2. Progression-free survival

    Time frame: 24 months

    Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.

  3. Conversion rate

    Time frame: 24 months

    Rate of patients underwent hepatic surgery after careful evaluation when an estimated residual liver volume >30-40% could be remained after R0 surgery by 2 experienced surgeons.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.