RFA or Surgical Resection Combined With Neo-MASCT for Primary HCC: a Phase II Trial

NCT ID: NCT03067493

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2023-03-31

Brief Summary

RAMEC is a phase II, multi-center, randomized trial with a safety test. There will be a safety test to establish the safety and tolerability of Neo-MASCT treatment and assess the immune response to the treatment.The randomized trial will assess DFS and immune response.

Detailed Description

The safety test will recruit 10 patients. Following registration they will receive 3 cycles of Neo-MASCT treatment. Patients will be seen at week 1, week 2 and week 4 of every cycle.

Following the safety test, 98 patients will be randomized to the trial across 3 recruiting centers. All patients on the treatment arm will complete up to 18 cycles of Neo-MASCT treatment. Patients on the control arm will be actively monitored after randomization. Blood samples for immune response test will be taken at baseline, cycle 1day 1 and then 3 monthly on day 1 of the subsequent cycles. The planned treatment duration will be until relapse of disease, unacceptable toxicity or withdrawal of consent. The end of the trial will be 24 months after the recruitment of the last patient.

Conditions

Primary Liver Cancer; Radiofrequency Ablation; Immunotherapy; Hepatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neo-MASCT group

Patients in the treatment group will receive a total of 6 courses of Neo-MASCT treatment. The whole period of Neo-MASCT treatment for each patient will be up to 24 months.Three stratification factors are considered, i.e.tumor size (2.1-3.0cm, 3.1-5.0cm), tumor number (1, \>1) and type of surgery (RFA，hepatectomy).

Group Type: EXPERIMENTAL

Neo-MASCT

Intervention Type: BIOLOGICAL

Patients assigned to Neo-MASCT treatment will receive 18 cycles of neo-MASCT (6 courses), with one cycle every month for the first year and one cycle every 2 months for the second year. Each cycle includes one DCs subcutaneous injection and one CTLs infusion.

Control group

Patients in the control group will be actively monitored during the trial period. Patients will receive assessment every 3 months in the first 3 years.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Neo-MASCT

Patients assigned to Neo-MASCT treatment will receive 18 cycles of neo-MASCT (6 courses), with one cycle every month for the first year and one cycle every 2 months for the second year. Each cycle includes one DCs subcutaneous injection and one CTLs infusion.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Aged ≥ 18 years;

2. Primary HCC received RFA/Hepatectomy as the initial treatment; a solitary tumour 2.0-5.0m in diameter; or 2-3 tumours with the largest ≤5.0cm; all without vascular invasion, lymphatic metastasis or distant metastasis (see Appendix 1 for diagnosis criteria).

3. ECOG 0/1 (Appendix 3);

4. Child-Pugh score 5-7 (Appendix 4);

5. A life expectancy of 6 months or more；

6. Adequate haematological, liver and renal function Neutrophil count ≥1.5 x 109/L; platelet count> 60 x 109/L; Haemoglobin concentration≥9.0 g/dL; Serum albumin≥ 3.0 g/dL; A total bilirubin of less than 1.5 times upper limit of normal; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times upper limit of normal; Prothrombin time ≤3s above the control Serum creatinine concentration of 1.5 times the upper limit of the normal range or less; CCR ≥60ml/min

7. Written informed consent

1. Imaging (enhanced CT or MRI) confirmed completely tumor necrosis or tumor removed 4 weeks after RFA/Hepatectomy；

2. Obtaining adequate samples of the matched tumor and adjacent nontumor normal liver tissues;

3. Sensitive mutations can be detected by gene sequencing in tumour tissue;

4. Prediction of neoantigen peptides ≥10;

5. Synthesized neo antigen peptides ≥5.

Exclusion Criteria

1. Pregnant women, lactating women or women planning to be pregnant in 2 years;

2. Intrahepatic metastasis, tumour thrombosis in main trunk or main branches of portal vein, tumour thrombosis in hepatic vein;

3. Systematic use of potent immunosuppressive agents within 6 months or long-term use of them such as corticosteroids, cyclosporine A, et al;

4. Concomitant HIV or HCV infection;

5. Concomitant immunodeficiency diseases or autoimmune diseases (eg. rheumatoid arthritis, Buerger's disease, multiple sclerosis and type I diabetes);

6. Concomitant malignancy or previous malignancy within 5 years before enrolment, excluding skin cancer, local prostate cancer or cervical carcinoma in situ;

7. Organ transplant recipients;

8. Patients with active auto-immune disorder, e.g. autoimmune hepatitis, systemic lupus erythematous etc.;

9. Severe dysfunction of the heart, kidney, or other organs;

10. Severe psychological dysfunction;

11. Sensitive to cytokines, any reagent or associated component in MASCT;

12. Ever participated in any clinical trial of other drugs within 3 months before enrolment;

13. Other patients that investigators think unsuitable to be enrolled.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Ming Kuang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Kuang, Ph.D.

Role: STUDY_CHAIR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Kuang, Ph.D.

Role: CONTACT

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

Facility Contacts

Ming Kuang, Ph.D.

Role: primary

kuangm@mail.sysu.edu.cn

008687755766 ext. 8576

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Other Identifiers

HCC008

Identifier Type: -

Identifier Source: org_study_id