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chemotherapy through intrahepatic arterial Infusion is one of the most widely used liver tumor treatments.

chemotherapy through Peripheral venous is one of the regularly used method.

Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.

Intrahepatic Arterial Infusion

dianrong xiu, doctor

Clinical results on intra-arterial adjuvant chemotherapy for prevention

of liver metastasis following curative resection of pancreatic cancer

In this study, the investigator try to select 80 patients who received radical surgery for pancreatic cancer, whose circulating tumor cells(CTCs) count then performed on intraoperative portal venous blood to predict postoperative liver metastasis and were divided into two groups. for those who have high CTCs count may have more chance for the occurrence of postoperative liver metastasis was applied hepatic arterial perfusion chemotherapy with minimal dynamic randomization. The aim is to evaluate the feasibility of hepatic arterial infusion chemotherapy for the prevention of postoperative liver metastasis and improvement of prognosis of pancreatic cancer, so as to further improve postoperative management of pancreatic cancer

Pancreatic cancer patients who received hepatic arterial perfusion chemotherapy after operation

Pancreatic cancer patients who received chemotherapy through peripheral vein after operation

Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery

Peking University Third Hospital

Heart and Blood Diseases

Carcinoma, Hepatocellular

Thrombosis

Micronutrients

Antineoplastic Agents

Leucovorin

Fluorouracil

Durvalumab

Oxaliplatin

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Immunologic Factors

The therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).

hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment

Hepatic artery infusion chemotherapy（HAIC）

Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose: Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).

Ming Zhao, M.D. & Ph.D.

Ning Lyu, M.D.

Ming Zhao, M.D.

Hepatic artery infusion chemotherapy (HAIC) and anti-programmed cell death protein-1ligand (PD-L1) immunotherapy have shown promising outcomes in patients with advanced hepatocellular carcinoma (HCC), respectively. However, the combination of the two treatments has not been reported. In this study, we will evaluate the the overall survival (OS)、efficacy and safety in patients with advanced hepatocellular carcinoma (Ad-HCC) with portal vein embolism who are undergoing hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment combined with anti-PD-L1 immunotherapy (Durvalumab) by designing an open, single-arm phase II clinical study.

Femoral artery puncture and catheterization were performed in every cycle of treatment,a micro-catheter was inserted and located in feeding hepatic artery. The therapeutic scheme was modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs were given by HAI.Patients received anti-PD-L1 agents will begin no earlier than 7 days following the first HAIC procedure. Anti-PD-L1 agents were used intravenously at the standard dose : Durvalumab was given every 3 weeks during HAIC treatment (Q3W) and every 4 weeks after HAIC treatment (Q4W).Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity.Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.

Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma

An Open Label Pilot Study to Evaluate Efficacy and Safety of Durvalumab(MEDI 4736) With Hepatic Artery Infusion Chemotherapy (HAIC) in the Chinese Advanced HCC Patients With Severe Portal Vein Tumor Thrombosis (PVTT)(Vp3 or Vp4) DurHope

Percentage of patients who survived one year after inclusion

It is defined as the percentage of patients who achieve a time interval of 1 year of no disease progression (i.e., intrahepatic recurrence or extrahepatic metastasis) or death (by any cause) from date of enrollment, whichever occurs first.

The percentage of patients who achieved a complete or partial response at some point in their life

Change in sub-scale and total scores of EORTC QLQ-HCC18 from baseline through follow-up.

Sun Yat-sen University

Associate Director of Minimally Invasive Intervention

Patients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC treatment.

There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.

Search of factors predicting therapeutic effects and prognosis

Ming Zhao, MD

Prospective single arm, single center observational study to evaluate factors which were easily available from preoperative examination for predicting therapeutic effects and clinical prognosis of hepatic artery infusion chemotherapy (HAIC) for hepatocellular carcinoma. There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination. Patients which are diagnosed with locally advanced hepatocellular carcinoma (HCC) will receive standard HAIC and follow-up exclusively as routinely done.

Hepatocellular carcinoma (HCC) remains a global health challenge and its incidence is growing worldwide. About 60%-70% of HCC patients were locally advanced or metastatic disease at the initial diagnosis, with a poor prognosis causing by unavailability of potentially curative therapies. Therefore, treatments that can control the progression and improve the prognosis of advanced HCC are under great need in sufficient liver reservation. Recent studies have shown that hepatic arterial infusion chemotherapy (HAIC) is beneficial to patients with locally advanced HCC. These studies have demonstrated that HAIC is superior to Sorafinib for the treatment of HCC with PVTT, whereas Sorafinib is recommended as first line treatment for locally advanced HCC. Therefore, HAIC is an important treatment option for locally advanced HCC. However, current tumor staging and prediction models for predicting the prognosis of HAIC for HCC is still unconvincing, and we found that some factors which were easily available from routine preoperative examination might be related to therapeutic effects and prognosis of HAIC for HCC. Thus, this prospective observational study aims to evaluate the value of these indicators for predicting therapeutic effects and prognosis of HAIC for HCC.

The standard procedure for HAIC is that femoral artery puncture and catheterization are performed in every cycle of treatment, a micro-catheter is inserted and located in feeding hepatic artery. The therapeutic scheme is modified FOLFOX6 regimens including oxaliplatin (130 mg/m2 infusion for 3 hours on day 1), leucovorin (200 mg/m2 from hour 3 to 5 on day 1) and Fluorouracil (400 mg/m2 in bolus, and then 2,400 mg/m2 continuous infusion 46 hours). All chemo-drugs are given by HAI. Treatment was repeated every 3 weeks and continued until intrahepatic lesions progression or unacceptable toxicity. Enhanced CT or MRI was performed every 6 weeks after treatment begins. Routine follow-up intervals were 2-4 months.

Before treatment, each patient will undergo routine hematological examinations which include blood routine, biochemical routine, coagulation routine, HCC related tumor markers. A three-phases enhanced CT or MR scan and biopsy of intrahepatic mass are performed before HAIC. Some factors through these examinations are collected and used to evaluate the relation of postoperative response rate and survival.

Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After HAIC for Locally Advanced HCC

Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After Hepatic Artery Infusion Chemotherapy (HAIC) for Locally Advanced Hepatocellular Carcinoma (HCC)

Tumor response to HAIC according to RECIST 1.1

Absence of disease progression other than death

Absence of regrowth inside the treated lesion

Absence of regrowth or onset of new lesions inside the liver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Application of Intrahepatic Arterial Infusion Chemotherapy for Patients With High Risk of Liver Metastases After Pancreatic Cancer Surgery	NCT03687853	Pancreatic Duct... Who Have High C... Liver Metastase...	Intrahepatic Ar...	18 Years - 70 Years	Peking University Third Hospital
Hepatic Artery Infusion Chemotherapy (HAIC) Plus Durvalumab for Advanced Hepatocellular Carcinoma	NCT04945720	Hepatocellular ...	Hepatic artery ... Durvalumab	18 Years - 75 Years	Sun Yat-sen University
Observational Study of Factors Predicting Therapeutic Effects and Clinical Prognosis After HAIC for Locally Advanced HCC	NCT05002452	Hepatocellular ...	Search of facto...	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for arterial infusion chemotherapy