HAIC With FOLFOX Versus Systemic Chemotherapy With GP for Unresectable ICC

Last updated: July 7, 2021
Sponsor: Shi Ming
Overall Status: Active - Recruiting

Phase

3

Condition

Liver Cancer

Digestive System Neoplasms

Biliary Tract Cancer

Treatment

N/A

Clinical Study ID

NCT04961970
S035B
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin compared systemic chemotherapy of gemcitabine and cisplatin in patients with unresectable intrahepatic cholangiocarcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The diagnosis of ICC
  • Patients must have at least one tumor lesion that can be accurately measured accordingto mRECIST criteria.
  • With no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Not amendable to surgical resection ,local ablative therapy and any other curedtreatment.
  • Without distant metastasis, but intrahepatic lymph node metastasis is allowed
  • The following laboratory parameters: Platelet count ≥ 50,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit ofnormal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3

Exclusion

Exclusion Criteria:

  • Evidence of hepatic decompensation including ascites, gastrointestinal bleeding orhepatic encephalopathy
  • Known history of HIV
  • History of organ allograft
  • Known or suspected allergy to the investigational agents or any agent given inassociation with this trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Evidence of bleeding diathesis.
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior tostudy entry.
  • Known central nervous system tumors including metastatic brain disease

Study Design

Total Participants: 188
Study Start date:
July 09, 2021
Estimated Completion Date:
July 09, 2025

Connect with a study center

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong 510060
    China

    Active - Recruiting

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