Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC

NCT03199807 | Unknown Phase 1 DMC

• 1 other identifier: Nanjing DrumTower Hospital
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.

Conditions

HCC

Keywords

HCC; NRT; TOMO radiotherapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with Adverse Events

  using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients

  up to 6 months

Secondary Outcomes (3)

• Response Rate

  3, 6 and 12 months

• Progression free survival (PFS)

  3, 6, 9 and 12 months

• Overall Survival (OS)

  At 6, 12 and 18 months

Other Outcomes (2)

• Th1/Th2 change in the peripheral blood

  At baseline,and 1 month, 3 months and 6 months

• Interferon-gama change of PBMC cells in the peripheral blood stimulated by tumor antigens

  At baseline,and 1 month, 3 months and 6 months

Study Arms (1)

NRT + radiotherapy

EXPERIMENTAL

HCC received NRT and radiotherapy

Biological: NRT; Radiation: Radiotherapy

Interventions

NRT BIOLOGICAL

Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory. NRTs 0.5\~1 x 10\^10, will be i.v.Q3 weeks for total 4-6 doses.

NRT + radiotherapy

Radiotherapy RADIATION

Radiotherapy of the major mass by dose of 5Gy/F \* 10F

NRT + radiotherapy

Eligibility Criteria

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

You may qualify if:

• Female or male aged 18 years and over, but no more than 75 years;
• Histologic or cytologic confirmation of advanced hepatocellular carcinoma;
• Patients with measurable lesions but can not be treated with surgery;
• Patients with two or over measurable lesions;
• ECOG≤0-2, Child-pugh A-B;
• Patients had not received systemic venous chemotherapy ever before;
• Hematology Index;
• Neutrophile granulocyte greater than 1.5×10\^9/L;
• Hemoglobin greater than 10g/dL;
• Platelet greater than 90×10\^9/L;
• Biochemical index
• Serum bilirubin not greater than 1.5x upper limit of reference range （ULN）
• ALT or AST not greater than 1.5x ULN
• Creatinine clearance no less than 60ml/min;
• Negative pregnancy test for women of childbearing potential;

You may not qualify if:

• Chemotherapy with experimental drug within 3 months before the start of study therapy;
• Have at least another primary malignant tumor;
• Active infection with bacterial or fungal infection;
• Patients with HIV infection, HCV infection, serious coronary artery disease or asthma, serious cerebrovascular disease or other diseases that the researchers think can not be entered into the group;
• Women who are pregnant or breast feeding;
• Drug abuse, clinical or psychological or social factors which will influence the informed. consent or the study implementation;
• May be allergic to immunotherapy;
• Radiotherapy and immunotherapy may not be implemented due to social or geographical factors;
• Weight loss greater 10% within 6 weeks before the start of study therapy;
• influence the safety or compliance of the patients.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Related Publications (1)

• Liu C, Shao J, Dong Y, Xu Q, Zou Z, Chen F, Yan J, Liu J, Li S, Liu B, Shen J. Advanced HCC Patient Benefit From Neoantigen Reactive T Cells Based Immunotherapy: A Case Report. Front Immunol. 2021 Jul 13;12:685126. doi: 10.3389/fimmu.2021.685126. eCollection 2021.

  PMID: 34326839 DERIVED

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Baorui Liu, M.D & Ph.D

  The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baorui Liu, M.D & Ph.D

CONTACT

+025-83106666; baoruiliu@nju.edu.cn

Jie Shen, M.D & Ph.D

CONTACT

+025-83106666; shenjie2008nju@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Model Details: NRT+radiotherapy

Study Record Dates

• First Submitted: June 18, 2017
• First Posted: June 27, 2017
• Study Start: July 20, 2017
• Primary Completion: July 20, 2020
• Study Completion: July 20, 2021
• Last Updated: June 27, 2017

Record last verified: 2017-06