- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03732547
Study of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma
A Phase II Study on the Safety and Therapeutic Effect of Combination of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Tingbo Liang, MD PhD
- Phone Number: +8615088682641
- Email: liangtingbo@zju.edu.cn
Study Contact Backup
- Name: Liang Wen, MD PhD
- Phone Number: +8619967413613
- Email: 11518214@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- The Second Affiliated Hospital of Zhejiang University
-
Contact:
- Liang Wen, MD PhD
- Phone Number: +8619967413613
- Email: 11518214@zju.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Hepatocellular carcinoma with imaging diagnosis, in barcelona stage C, or stage B but resistant/recurrent to prior local treatment (e.g., TACE).
- Eastern cooperative oncology group physical fitness score: 0-2.
- Predicted survival time≥3 months.
- Liver function of Child-Pugh A-B, no hepatic encephalopathy or physical examined ascites.
Routine blood tests were in accordance with the following criteria:
White blood cell (WBC)≥2.0x10^9/L, Neutrophil≥1.0x10^9/L, platelet (PLT)≥50x10^9/L, hemoglobin (HB)≥80 g/dL, creatinine≤1.5xULN (upper limit of normal value), Alanine transaminase (ALT) and aspartate aminotransferase (AST)≤5xULN, total bilirubin (TB)≤51.3umol/L, international normalized ratio (INR) or prothrombin time (PT)≤1.7xULN, activated partial thromboplastin time (APTT)≤1.5xULN, serum albumin≥28g/L
- Patients will be informed consent, and understand and are willing to cooperate with the trial and sign related documents.
Exclusion Criteria:
- Has a history of malignant tumor in last 2 years, except basal and skin squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, superficial bladder cancer and carcinoma in situ of breast.
- Received the treatment of polyIC or immune checkpoint inhibitors (e.g., PD-1/PD-L1 mAb or CTLA-4 mAb) in last 2 years.
- Received the therapies of multi-kinase inhibitors (e.g., sorafenib, regorafenib), systemic chemotherapy, local therapy (e.g., TACE, radiotherapy), vaccination, immunomodulating therapy (e.g., interleukins, thymosin) or any other clinical trial in last 4 weeks.
- Received any corticosterone or immunosuppressive drug in last 2 weeks.
- Toxicity induced by previous anti-tumor therapies has not returned to the status of baseline or stability.
- HIV positive (including previous anti-retroviral therapy), active HCV infection or active syphilis.
- Any severe liver disease (e.g., severe liver cirrhosis, severe liver adenoma)
- Any active or recurrent autoimmune disease.
- Any interstitial pneumonia, non-infectious pneumonia, or uncontrolled systemic disease (e.g., uncontrolled hypertension or diabetes).
- Severe cardiovascular risk factors.
- Has a history of allogeneic stem cell transplantation or organ transplantation.
- Imaging confirmed brain or meninges metastases.
- Has the plan of pregnancy, or lactation.
- Any kind of psychiatric disease or laboratory test abnormality that may result in the subject's failure to fully comply with the laboratory protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 'PolyIC plus PD-1 mAb' and 'PD-1 mAb'
'PolyIC plus PD-1 mAb' group: PolyIC, 2mg, i.m., every other day, for three weeks. PD-1 mAb, 200mg, i.v., every three weeks. 'PD-1 mAb' group: PD-1 mAb, 200mg, i.v., every three weeks. |
Intravenous infusion of PD-1 mAb, 200mg, once a time, every three weeks.
Other Names:
Intramuscular injection of polyIC, 2mg, every other day, for three weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective response rate (ORR)
Time Frame: Up to approximately 5 years
|
Percentage of patients whose cancer shrinks or disappears after treatment
|
Up to approximately 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: Up to approximately 5 years
|
Percentage of patients whose cancer doesn't progress after treatment
|
Up to approximately 5 years
|
Progression free survival (PFS)
Time Frame: Up to approximately 5 years
|
The percentage of people does not get worse for a period of time after diagnosis
|
Up to approximately 5 years
|
Overall survival (OS)
Time Frame: Up to approximately 5 years
|
The percentage of people still alive for a given period of time after diagnosis
|
Up to approximately 5 years
|
Number of participants with treatment-related adverse events
Time Frame: Up to approximately 5 years
|
Number of participants with treatment-related adverse events after drug initiation, as assessed by CTCAE v4.0
|
Up to approximately 5 years
|
Percentage of participants with a better life quality
Time Frame: Up to approximately 5 years
|
The percentage of participants with a better life quality after treatment, assessed by the questionnaires of European Organization for Research and Treatment of Cancer Quality of Life
|
Up to approximately 5 years
|
Level of alpha-fetoprotein (AFP)
Time Frame: Up to approximately 5 years
|
The percentage of participants with a decreased serum level of alpha-fetoprotein (AFP) after treatment
|
Up to approximately 5 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Immunologic Factors
- Interferon Inducers
- Poly I-C
Other Study ID Numbers
- CISLD-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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