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

NCT05002452 | Unknown DMC

• 1 other identifier: B2021-107-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Arterial infusion chemotherapy; FOLFOX

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Absence of death of any cause

  3-years Followed up

• Tumor Response

  Tumor response to HAIC according to RECIST 1.1

  3-years Followed up

Secondary Outcomes (4)

• Progress Free Survival

  3-years Followed up

• Tumor local control

  3-years Followed up

• Hepatic control

  3-years Followed up

• Distant control

  3-years Followed up

Study Arms (1)

Locally Advanced HCC Patients

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

Other: Search of factors predicting therapeutic effects and prognosis

Interventions

Search of factors predicting therapeutic effects and prognosis OTHER

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

Locally Advanced HCC Patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients which are diagnosed with locally advanced HCC will receive standard HAIC and follow-up exclusively as routinely done.

You may qualify if:

• Written informed consent must be obtained prior to any screening procedures.
• Cytohistological confirmation is required for diagnosis of HCC.
• Patients with advanced (unresectable and/or metastatic, stage C based on Barcelona-Clinic Liver Cancer \[BCLC\] staging classification) hepatocellular carcinoma which would not be suitable for treatment with loco-regional therapies or have progressed following locoregional therapy such as surgical resection, percutaneous hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy.
• At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1. Lesions previously treated with local therapy, such as radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy should not be selected unless progression is noted at baseline, in which case, these lesions would be considered as non-target lesions.
• Current cirrhotic status of Child-Pugh class A-B, with no encephalopathy. Ascites controlled by diuretics is permitted in this study.
• Availability of a representative tumor tissue specimen (archival tumor tissue is allowed) at pre-screening.
• Eastern Cooperative Oncology Group Scale for Assessment of Patient Performance Status ≤ 2.
• Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial.
• Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to procedure:
• Hemoglobin \> 100g/L
• Absolute neutrophil count \>3.0 ×109/L
• Neutrophil count \> 1.5 ×109/L
• Platelet count ≥ 50.0 ×109/L
• Total bilirubin \< 51 μmol/L
• Alanine transaminase (ALT) and aminotransferase (AST) \< 5 x upper limit of normal

You may not qualify if:

• Received any prior systemic chemotherapy or molecular-targeted therapy for HCC such as sorafenib, lenvatinib.
• Previous local therapy completed less than 4 weeks prior to the dosing and, if present any related acute toxicity \> grade 1.
• Any contraindications for hepatic arterial infusion procedure:
• Impaired clotting test (platelet count \< 60000/mm3, prothrombin activity \< 50%).
• Renal failure / insufficiency requiring hemo-or peritoneal dialysis.
• Known severe atheromatosis.
• Known uncontrolled blood hypertension (\> 160/100 mm/Hg).
• Patients with any other malignancies within the last 3 years before study start.
• History of HCC tumor rupture.
• Patients with severe encephalopathy.
• Patients with known active bleeding (e.g. from GI ulcers, esophageal varices) within 2 months prior to baseline/screening visit or with history or evidence of inherited bleeding diathesis or coagulopathy.
• Clinically significant (CTC grade 3 or 4) venous or arterial thrombotic disease within past 6 months.
• History of cardiac disease:
• Congestive heart failure \>New York Heart Association (NYHA) class 2 (refer to Appendix 13.9).
• Active coronary artery disease (CAD) (myocardial infarction more than 6 months prior to study entry is allowed).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Minimally Invasive and Interventional Radiology, Liver Cancer Study and Service Group, Sun Yat-sen University Cancer Center,

Guangzhou, Guangdong, 500060, China

RECRUITING

Related Publications (2)

• Lyu N, Kong Y, Mu L, Lin Y, Li J, Liu Y, Zhang Z, Zheng L, Deng H, Li S, Xie Q, Guo R, Shi M, Xu L, Cai X, Wu P, Zhao M. Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma. J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.

  PMID: 29471013 BACKGROUND

• Lyu N, Lin Y, Kong Y, Zhang Z, Liu L, Zheng L, Mu L, Wang J, Li X, Pan T, Xie Q, Liu Y, Lin A, Wu P, Zhao M. FOXAI: a phase II trial evaluating the efficacy and safety of hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin for advanced hepatocellular carcinoma. Gut. 2018 Feb;67(2):395-396. doi: 10.1136/gutjnl-2017-314138. Epub 2017 Jun 7. No abstract available.

  PMID: 28592441 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ming Zhao, M.D.

  Department of Minimally Invasive and Interventional Radiology, Liver Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Zhao, M.D.

CONTACT

+86-20-87343272; zhaoming@sysucc.org.cn

Ning Lyu, M.D.

CONTACT

+86-20-87343272; zhaoming@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 12, 2021
• Study Start: December 20, 2021
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

CN (1)