Clinical trial NCT05489692: HAIC Plus Targeted Therapy and/or PD-1 Inhibitors for Unresectable Intrahepatic Cholangiocarcinoma
Official title: Hepatic Arterial Infusion Chemotherapy Plus Targeted Therapy and/or PD-1 Inhibitors as Conversion Treatment for Unresectable Intrahepatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intrahepatic Cholangiocarcinoma
Keywords: Hepatic Arterial Infusion Chemotherapy
Targeted Therapy
PD-1 Inhibitors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We reviewed data of patients diagnosed as ICC according to pathology or typical imaging presentation with elevated CA-199 between September 2017 and October 2021 at Sun Yat-Sen University Cancer Center. Patients with ICC confined to the liver and/or regional lymph nodes and treated by FOLFOX-HAIC combined with targeted therapy and anti-PD-1 therapy were evaluated.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients were initially diagnosed without any previous oncological treatment.
2. 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.
3. At least one assessable intrahepatic lesion.
4. classified as Child-Pugh Grade A.
5. ECOG PS score 0-1.
6. 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:

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

Primary outcomes:
measure: Tumor Response
timeFrame: 12 months
Secondary outcomes:
measure: Overall survival
timeFrame: 24 months
measure: Progression-free survival
timeFrame: 24 months
measure: Conversion rate
timeFrame: 24 months
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan
role: PRINCIPAL_INVESTIGATOR
References: