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The Treatment of Advanced Lung Cancer With Dribbles Antigen by Targeting Activation of Tcells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03057340
Recruitment Status : Unknown
Verified February 2017 by Second Affiliated Hospital, School of Medicine, Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : February 20, 2017
Last Update Posted : February 20, 2017
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:

Malignant tumor has become the leading cause of death in humans, and the number one killer in malignant tumor is the lung cancer. Intensifying environmental pollution comes with rising of the incidence of lung cancer and the high mortality,what's the worst that the 5-year survival rate is only about 15%, accounting for first place in the malignant tumors, Exploiting for novel antitumor technology and products comes to arrest growing attention of the governments and businesses because of the uneffectively curbing of tumor threat to people's life and health on conventional three treatments (surgery, radiotherapy and chemotherapy). Biological and immunotherapy was voted to one of the ten big breakthrough in 2013 by Science magazine, and considered as a new development direction for cancer treatment in the 21st century.

The existing immune treatment mainly includes: adoptive immune therapy, tumor vaccine therapy, immune checkpoint-antibody therapy and other auxiliary therapy, and the adoptive immunotherapy was researched and developeded former in addition the most mature treatment among these therapies.

Recently, Dr Hu Hong - Ming's team put forward an innovative cancer treatment strategy: using of autophagy role to capture tumor antigen for preparation of tumor vaccine. In this strategy, the blocking proteasome activity of in vitro cultured tumor cells dealed with Bortezomib (proteasome inhibitors) causes enrichment of short-lived protein (SLiPs) and misfolded proteins (DRiPs) in autophagosome,called DRibbles corpuscle. Tumor vaccine maded from collecting these DRibbles corpuscle preparation as, also known as the DRibble vaccine.

At present, clinical research has been carried out about Dribble liver cancer vaccine unit with DC - CIK therapy in liver cancer in the second hospital of Nanjing nearly four years,and more than 300 cases has been completed. Clinical research results show that Dribble vaccine has good security, producing stronger immune response compared with the DC-CIK therapy alone. But it is still no cognization for the efficacy and safety of DC-CIK joint DRibble lung cancer vaccine in China, whether it is better than the current DC - CIK immune therapy, needed for further clinical research and expected to provide a better immune treatment for NSCLC patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: Dribble vaccine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Advanced Lung Cancer With Dribbles Antigen by Targeting
Estimated Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DRibble vaccine
Blood samples collection: collect of 10ml patients peripheral blood, separate PBMC;Day 1: DRibble group guided by ultrasound in patients with inguinal lymph nodes injected the DRibble vaccine;Day8: collecte 50 ml peripheral blood and separate monocytes and lymphocytes;Intensify immune cells amplification;Identification of immune cell;Detection of Immune cells microbial;20-22 days: immune cells back to patients;55 days: collecte 10 ml peripheral blood, after the separation of PBMC in vitro induced to DC, cocultivate with DRibble and subcutaneous injection at 60th day;Day 75: collecte 10 ml peripheral blood, separate PBMC and detecte T cell immune response ability.
Biological: Dribble vaccine
DRibble vaccine with DC/CIK(The experimental group) DRibble vaccine will be administered at day1,22,55

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 2 years ]
    Evaluate progression-free survival. Tumor measurements by CT scan will be obtained at week 16 and subsequently at the discretion of the treating investigator. After the treatment period, patients will be seen every 3 months for 2 years, or until progressive disease.

Secondary Outcome Measures :
  1. Safety: to evaluate the overall safety of allogeneic NSCLC DRibble vaccine alone or in combination with either imiquimod or GM-CSF [ Time Frame: 43 weeks ]
    To evaluate the overall safety of allogeneic NSCLC DRibble vaccine alone or in combination with either imiquimod or GM-CSF, as adjuvant treatment for definitively-treated patients with Stage IIIA or B NSCLC. During the treatment period, patients will be seen in clinic 13 times over a 22-week period; performance status and side-effects will be evaluated at each visit.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Aged 18-80 years old, pathological diagnosis of advanced non-small cell lung cancer, after treatment with radiation and chemotherapy and (or) targeted drugs disease still progress.
  • Clear that heart, lung, liver, kidney at physical basic normal, and basic normal immune system function.
  • No allergic reaction of biological products, asthma and other allergic constitution.
  • A patient or his legal representative signed informed consent.

Exclusion Criteria:

  • The obvious blood coagulation dysfunction patients.
  • Patients infected with tuberculosis, hepatitis b, AIDS and syphilis positive diseases.
  • Severe diabetes, high blood pressure, stroke, heart failure, and kidney disease.
  • Autoimmune diseases such as systemic lupus erythematosus (sle) and Rheumatoid arthritis (ra)
  • Large doses or long-term glucocorticoid, and other immunosuppressive users (more than 4 weeks).
  • Pregnant and nursing women has a history of allergies of biological products.
  • Collect blood and doping in another place.
  • Allergies or active infection that effect the observation of Tolerance activity.
  • Heart, lung, liver, kidney or bone marrow function obviously low.
  • Unable or unwilling to sign a consent form or to comply with the technical requirement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03057340

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Contact: PingLi Wang, Doctor 13516808409

Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Study Chair: Kai Wang, Doctor The second hospital affiliated to zhejiang university school of medicine
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University Identifier: NCT03057340    
Other Study ID Numbers: pl001
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
Advanced non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms