HCCPhase 1/2LCRAI-1NCT03199807
Phase IB/II Study of NRT Combined With Radiotherapy for Advanced HCC
A Phase 1/2 study testing NRT and Radiotherapy in people with HCC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCC
- What is being tested?
- NRT and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2017to 20 Jul 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Provision of informed consent;
- Be able to follow the research program and follow up process;
- Expected survival time 3 months or more.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients
The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Read the detailed description
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. 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
- Being tested
- NRT, Radiotherapy
- Keywords
- HCC, NRT, TOMO radiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRTBiological
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.
RadiotherapyRadiation
Radiotherapy of the major mass by dose of 5Gy/F * 10F
| Study group | Role | What they receive |
|---|---|---|
| NRT + radiotherapy | Experimental | HCC received NRT and radiotherapy Receives: Biological: NRT; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
Measured: up to 6 months
Secondary outcomes (3)
Response Rate
Response Rate（RR） will be evaluated according Response Evaluation Criteria
Measured: 3, 6 and 12 months
Progression free survival (PFS)
the duration of progression free survival is measured from the time of treatment to the first date that recurrent or progressive disease or for any reason of death is objectively documented
Measured: 3, 6, 9 and 12 months
Overall Survival (OS)
the duration is measured from the time of treatment to the time of death
Measured: At 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start20 Jul 2017 (estimated)
- Primary completion20 Jul 2020 (estimated)
- Study completion20 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCCStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- NRT+radiotherapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhengyun Zou, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Investigators
- Baorui Liu, M.D & Ph.D, Principal investigator, The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199807
- Sponsor's protocol ID
- Nanjing DrumTower Hospital
- Acronym
- LCRAI-1
- Status last verified
- Jun 2017
- First submitted
- 18 Jun 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34326839
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IB/II Study of Personalized New Antigen Reactive Immune Cells (NRT) Combined With Radiotherapy for Advanced Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT03199807
- Acronym / sponsor ID
- LCRAI-1 / Nanjing DrumTower Hospital
- Conditions
- HCC
- Keywords
- HCC, NRT, TOMO radiotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 20 Jul 2017 (estimated)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 20 Jul 2021 (estimated)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Detailed description
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer-related death worldwide. The resection rate for HCC is approximately 10%-30% and the overall prognosis is very poor with a 5-year survival rate of 5%-6%. The recurrence rate is high after radical resection. In addition to surgery, radiofrequency ablation, transcatheter arterial chemoembolization (TACE), microwave ablation, cryoablation, radioactive seeds implantation, high-intensity-focused ultrasound, radiation therapy, chemotherapy and targeted drugs are available for patients with unresectable tumors; however, the efficacy of these treatments are limited and long-term prognosis in the patients is still poor. Moreover, due to serious side effects induced by treatments such as TACE, chemotherapy and targeted drugs, it may not be possible for patients to continue receiving these therapies. The study herein successfully developed a new immunotherapeutic approach combined with radiotherapy, and tried to proved it to be more effective and safe.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- NRT+radiotherapy
| Arm | Type | Receives |
|---|---|---|
| NRT + radiotherapy | Experimental | Biological: NRT, Radiation: RadiotherapyHCC received NRT and radiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NRTPeripheral 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. | Biological | NRT + radiotherapy |
| RadiotherapyRadiotherapy of the major mass by dose of 5Gy/F * 10F | Radiation | NRT + radiotherapy |
Primary outcome
Number of participants with Adverse Events
Time frame: up to 6 months
using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients
3 secondary outcomes
Response Rate
Time frame: 3, 6 and 12 months
Progression free survival (PFS)
Time frame: 3, 6, 9 and 12 months
Overall Survival (OS)
Time frame: At 6, 12 and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Derived from this study: PubMed 34326839Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baorui Liu, M.D & Ph.D principal investigator
The Comprehensive Cancer Centre of Drum Tower Hospital, Medical School of Nanjing University, Clinical Cancer Institute of Nanjing University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NRT and Radiotherapy in people with HCC, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baorui Liu, M.D & Ph.D (+025-83106666 ext. 61331, baoruiliu@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03199807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.