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.

• ClinicalTrials.gov Identifier: NCT03192618
• Recruitment Status: Recruiting
• First Posted: June 20, 2017
• Last Update Posted: June 20, 2017
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Rong-ping Guo, Sun Yat-sen University

Tracking Information

• First Submitted Date: June 16, 2017
• First Posted Date: June 20, 2017
• Last Update Posted Date: June 20, 2017
• Estimated Study Start Date: July 1, 2017
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 19, 2017)

Disease-free survival (DFS) [ Time Frame: From date of randomization until the date of recurrence, assessed up to 60 months ]

disease-free survival

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 19, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• Official Title: 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma

Intervention

• Procedure: adjuvant transarterial chemoinfusion (TAI)
  transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
• Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
  oxaliplatin, calcium folinate, and 5-FU

Study Arms

• Experimental: treatment group
  Interventions:

  • Procedure: adjuvant transarterial chemoinfusion (TAI)
  • Drug: mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
• No Intervention: control group

• Publications *: 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. 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. Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16. Erratum In: Ann Surg Oncol. 2021 Dec;28(Suppl 3):874.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 19, 2017): 290
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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;

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Shaohua Li, MD; +8615088064187; lishaoh@sysucc.org.cn

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03192618
• Other Study ID Numbers: B2017-006-01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Rong-ping Guo, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sun Yat-sen University
• Verification Date: June 2017