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

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Brief Title

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

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.
    



Study Type

Observational


Primary Outcome

Tumor Response

Secondary Outcome

 Overall survival

Condition

Intrahepatic Cholangiocarcinoma

Intervention

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

Study Arms / Comparison Groups

 FOLFOX-HAIC plus targeted therapy and/or PD-1 inhibitors
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

43

Start Date

September 1, 2017

Completion Date

January 31, 2022

Primary Completion Date

August 31, 2021

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yunfei Yuan, , 

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05489692

Organization ID

B2022-222-01


Responsible Party

Principal Investigator

Study Sponsor

Sun Yat-sen University


Study Sponsor

Yunfei Yuan, Principal Investigator, Sun Yat-sen University


Verification Date

August 2022