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

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05489692
• Other study ID #: B2022-222-01
• Status: Completed
• Start date: September 1, 2017
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2022
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: January 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Procedure:
• hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX)
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Response	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	12 months
Secondary	Overall survival	Overall survival (OS) was measured from the initiation of transarterial therapy to the date of death or the last follow-up.	24 months
Secondary	Progression-free survival	Progression-free survival (PFS) was measured from the initiation of transarterial therapy to the time of progression or recurrence or last follow-up.	24 months
Secondary	Conversion rate	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.	24 months