Clinical trial NCT02709070: Resection+Highly Purified CTL Versus Resection Alone for HCC
Official title: Resection Combined With Highly-purified CTL Versus Resection Alone for HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Keywords: highly-purified CTL
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is little evidence showed that adjuvant therapy had been shown to extend the survival of patients with hepatocellular carcinoma (HCC) receiving surgical resection. We investigated whether injections of highly-purified Cytotoxic T lymphocytes prolongs recurrence-free survival of patients after resection for HCC.

Detailed description: Hepatocellular carcinoma (HCC) is the fifth most common and the third leading cause of cancer-related death worldwide. Resection is considered as the main curative treatment for HCC, but recurrence of tumor within the liver remnant is common, with a reported 5-year recurrence rate of 70%, which results in poor prognosis of HCC, and the high recurrence rate has led efforts to develop adjuvant therapies to reduce recurrence. However, the benefit of any form of adjuvant therapy remains unclear. Current guidelines didn't recommend any adjuvant therapy after resection. A previous clinical trial from Japan reported that cytokine-induced killer(CIK) cell immunotherapy increased recurrence-free survival (RFS) after surgical resection of HCC. Immunotherapy has become an optional treatment for HCC. Cytotoxic T lymphocytes(CTL), a kind of effective T cells that specific recognizing and killing antigen targeted cells through cloning amplification after receiving antigen information from antigen presented cell and playing key role to clear cancerous cells. There is little evidence for adjuvant CTL treatment for HCC receiving resection. So our hypothesis is that adjuvant highly-purified CTL is superior to resection alone for HCC. The aim of this prospective study is to compare the outcome of resection combined with highly-purified CTL with resection for HCC.

Eligibility criteria: Inclusion Criteria:

* 1. Age 18-75 years; 2. First diagnosed HCC, no other treatment received; 3.Child-pugh A-B 4. No severe coagulation disorders (prothrombin activity\<40% or a platelet count\<40,000/mm3); 5. Eastern Co-operative Oncology Group performance(ECOG) status 0-1.

Exclusion Criteria:

* 1. Pregnant women, breastfeeding women or plan pregnancy for the future 2 years; 2. The presence of vascular invasion or extrahepatic spread on imaging; 3. Usage of strong immunosuppressive agents such as corticosteroids, cyclosporine A within six months or longer; 4. HIV antibody or hepatitis C virus antibody positive; 5. Immunodeficiency diseases or autoimmune diseases (such as rheumatoid arthritis, Buerger's disease, multiple sclerosis and type 1 diabetes); 6. Suffering with cancers (except skin cancer, prostate cancer or cervical carcinoma in situ) at the enrolling time or 5 years before; 7. Suffering with other organ failure; 8. Suffering with severe mental illness; 9. Drug addiction (including alcohol) for 1 year before the enrolling time; 10. Participate in other Clinical trials within three months prior to 3 months before the enrolling time; 11. Other researchers believe that the patient is not fit for inclusion.

Primary outcomes:
measure: recurrence free survival
timeFrame: 2-year
Secondary outcomes:
measure: overall survival
timeFrame: 5-year
Other outcomes:
Locations:
Study officials:
References:
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