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

Hepatocellular Carcinoma Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

• NCT number: NCT05002452
• Study type: Observational
• Source: Sun Yat-sen University
• Contact: Ming Zhao, M.D.
• Phone: +86-20-87343272
• Email: zhaoming@sysucc.org.cn
• Status: Recruiting
• Start date: December 20, 2021
• Completion date: December 1, 2025