The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

Conditions

Hepatocellular Carcinoma

Brief summary

To compare The Impact on Recurrence Risk of Adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Microvascular Invasion (MVI) After Hepatectomy.

Lidi Ma, Cheng Zhang, Yuhua Wen, Kaili Xing, Shaohua Li et al. (18 authors)

International Journal of Surgery2024-07-245 citations

10.1097/js9.0000000000001903

Postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX to improve outcomes of patients with hepatocellular carcinoma with microvascular invasion: A prospective multicenter, phase 3, randomized, controlled clinical trial.

Shaohua Li, Jie Mei, Yuan Cheng, Qiang Li, Qiaoxuan Wang et al. (20 authors)

Journal of Clinical Oncology2022-06-014 citations

10.1200/jco.2022.40.16_suppl.4013

Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.

Li S, Mei J, Wang Q, Guo Z, Lu L, Ling Y, Xu L, Chen M, Zheng L, Lin W, Zou J, Wen Y, Wei W, Guo R.

2020-05-1642 citations

10.1245/s10434-020-08601-8

Postoperative adjuvant transarterial infusion chemotherapy with FOLFOX could improve outcomes of hepatocellular carcinoma patients with microvascular invasion: A preliminary report of a phase III, randomized, controlled clinical trial.

Shaohua Li, Wei Wei, Qiaoxuan Wang, Zhixing Guo, Jie Mei et al. (13 authors)

Journal of Clinical Oncology2020-02-0111 citations

10.1200/jco.2020.38.4_suppl.527

Interventions

PROCEDUREadjuvant transarterial chemoinfusion (TAI)

transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

DRUGmFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

oxaliplatin, calcium folinate, and 5-FU

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

* older than 18 years old and younger than 75 years; * ECOG PS\<3; * proven hepatocellular carcinoma with MVI according pathological examination; * not previous treated for tumor; * tumor was removed in operation; * no recurrence occurence at 4 to 7 weeks after surgery; * the lab test could meet: neutrophil count≥1.5×109/L; hemoglobin≥80g/L; platelet count≥60×109/L; serum albumin≥28g/L; total bilirubin\<3-times upper limit of normal; ALT\<5-times upper limit of normal; AST\<5-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 6 seconds; INR≤2.3; * sign up consent; * unrolled by other clinical trials about hepatocellular carcinoma.

Exclusion criteria

* cannot tolerate TAI; * CNS or bone metastasis exits; * known history of other malignancy; * be allergic to related drugs; * underwent organ transplantation before; * be treated before (interferon included); * known history of HIV infection; * known history of drug or alcohol abuse; * have GI hemorreage or cardiac/brain vascular events within 30 days; * pregnancy;

Design outcomes

Primary

Measure	Time frame	Description
Disease-free survival (DFS)	From date of randomization until the date of recurrence, assessed up to 60 months	disease-free survival

Secondary

Measure	Time frame	Description
recurrence rate	1 year, 2 year, 3 year, 5 year after surgery	recurrence rate
Overall survival (OS)	From date of randomization until the date of death from any cause, assessed up to 60 months	overall survival

Countries

China

Contacts

Primary ContactShaohua Li, MD

lishaoh@sysucc.org.cn+8615088064187

Outcome results

None listed