Carcinoma, HepatocellularPhase 2NCT03732547
Study of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma
A Phase 2 study testing PD-1 mAb and PolyIC in people with Carcinoma, Hepatocellular, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
When multi-kinase inhibitors based therapies (sorafenib and regorafenib) are limited in late-stage liver cancer patients, there is no alternative options. PD-1 blockade has became a promising immunotherapeutic strategy in many cancers. While it showed limited efficacy in liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- PD-1 mAb and PolyIC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2018to 22 Oct 2023
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Liang Wen, MD PhD, +8619967413613, 11518214@zju.edu.cn
About this study
Official title: A Phase II Study on the Safety and Therapeutic Effect of Combination of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma
When multi-kinase inhibitors based therapies (sorafenib and regorafenib) are limited in late-stage liver cancer patients, there is no alternative options. PD-1 blockade has became a promising immunotherapeutic strategy in many cancers. While it showed limited efficacy in liver cancer. Polyinosinic-polycytidylic acid (PolyIC) has been widely studied as a new anti-tumor drug and recent study showed that polyIC and PD-L1 mAb has a quite synergetic effect on the hepatocellular carcinoma (HCC). This study is aimed to evaluate the safety and efficacy of the combination of PolyIC and PD-1 mAb in unresectable late-stage HCC patients.
Read the detailed description
Nowadays, primary liver cancer, especially hepatocellular carcinoma (HCC) has become the second leading cause of cancer-related death. Unfortunately, the therapeutic strategies are still limited for HCC. For HCC patients at advanced stage, up to now, sorafenib and regorafenib are applied for palliative therapy to prolong the patients' life. PD-1 blockade has became a promising immunotherapeutic strategy in many cancers. While it showed limited efficacy in liver cancer. Polyinosinic-polycytidylic acid (PolyIC) has been widely studied as a new anti-tumor drug and recent study showed that polyIC and PD-L1 mAb has a quite synergetic effect on the treatment of HCC. This study is aimed to evaluate the safety and efficacy of the combination of PolyIC and PD-1 mAb in unresectable late-stage HCC patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- PD-1 mAb, PolyIC
- Keywords
- Hepatocellular carcinoma, Polyinosinic-polycytidylic acid, PD-1 mAb
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 mAbDrug
Also called Programmed cell death-1 monoclonal antibody
Intravenous infusion of PD-1 mAb, 200mg, once a time, every three weeks.
PolyICDrug
Also called Polyinosinic-polycytidylic acid
Intramuscular injection of polyIC, 2mg, every other day, for three weeks.
| Study group | Role | What they receive |
|---|---|---|
| 'PolyIC plus PD-1 mAb' and 'PD-1 mAb' | Experimental | '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. Receives: Drug: PD-1 mAb; Drug: PolyIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Percentage of patients whose cancer shrinks or disappears after treatment
Measured: Up to approximately 5 years
Secondary outcomes (6)
Disease control rate (DCR)
Percentage of patients whose cancer doesn't progress after treatment
Measured: Up to approximately 5 years
Progression free survival (PFS)
The percentage of people does not get worse for a period of time after diagnosis
Measured: Up to approximately 5 years
Overall survival (OS)
The percentage of people still alive for a given period of time after diagnosis
Measured: Up to approximately 5 years
Number of participants with treatment-related adverse events
Number of participants with treatment-related adverse events after drug initiation, as assessed by CTCAE v4.0
Measured: Up to approximately 5 years
Percentage of participants with a better life quality
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
Measured: Up to approximately 5 years
Level of alpha-fetoprotein (AFP)
The percentage of participants with a decreased serum level of alpha-fetoprotein (AFP) after treatment
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start22 Oct 2018
- Primary completion22 Oct 2021 (estimated)
- Study completion22 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tingbo Liang, MD PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732547
- Sponsor's protocol ID
- CISLD-1
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study on the Safety and Therapeutic Effect of Combination of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03732547
- Acronym / sponsor ID
- CISLD-1
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular carcinoma, Polyinosinic-polycytidylic acid, PD-1 mAb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 22 Oct 2021 (estimated)
- Study completion
- 22 Oct 2023 (estimated)
- First posted
- 6 Nov 2018 (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.
When multi-kinase inhibitors based therapies (sorafenib and regorafenib) are limited in late-stage liver cancer patients, there is no alternative options. PD-1 blockade has became a promising immunotherapeutic strategy in many cancers. While it showed limited efficacy in liver cancer. Polyinosinic-polycytidylic acid (PolyIC) has been widely studied as a new anti-tumor drug and recent study showed that polyIC and PD-L1 mAb has a quite synergetic effect on the hepatocellular carcinoma (HCC). This study is aimed to evaluate the safety and efficacy of the combination of PolyIC and PD-1 mAb in unresectable late-stage HCC patients.
Detailed description
Nowadays, primary liver cancer, especially hepatocellular carcinoma (HCC) has become the second leading cause of cancer-related death. Unfortunately, the therapeutic strategies are still limited for HCC. For HCC patients at advanced stage, up to now, sorafenib and regorafenib are applied for palliative therapy to prolong the patients' life. PD-1 blockade has became a promising immunotherapeutic strategy in many cancers. While it showed limited efficacy in liver cancer. Polyinosinic-polycytidylic acid (PolyIC) has been widely studied as a new anti-tumor drug and recent study showed that polyIC and PD-L1 mAb has a quite synergetic effect on the treatment of HCC. This study is aimed to evaluate the safety and efficacy of the combination of PolyIC and PD-1 mAb in unresectable late-stage HCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 'PolyIC plus PD-1 mAb' and 'PD-1 mAb' | Experimental | Drug: PD-1 mAb, Drug: PolyIC'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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| PD-1 mAbAlso: Programmed cell death-1 monoclonal antibodyIntravenous infusion of PD-1 mAb, 200mg, once a time, every three weeks. | Drug | 'PolyIC plus PD-1 mAb' and 'PD-1 mAb' |
| PolyICAlso: Polyinosinic-polycytidylic acidIntramuscular injection of polyIC, 2mg, every other day, for three weeks. | Drug | 'PolyIC plus PD-1 mAb' and 'PD-1 mAb' |
Primary outcome
Objective response rate (ORR)
Time frame: Up to approximately 5 years
Percentage of patients whose cancer shrinks or disappears after treatment
6 secondary outcomes
Disease control rate (DCR)
Time frame: Up to approximately 5 years
Progression free survival (PFS)
Time frame: Up to approximately 5 years
Overall survival (OS)
Time frame: Up to approximately 5 years
Number of participants with treatment-related adverse events
Time frame: Up to approximately 5 years
Percentage of participants with a better life quality
Time frame: Up to approximately 5 years
Level of alpha-fetoprotein (AFP)
Time frame: Up to approximately 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- 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.
Tingbo Liang, MD PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD-1 mAb and PolyIC in people with Carcinoma, Hepatocellular, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 7 inclusion and 14 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 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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 Tingbo Liang, MD PhD (+8615088682641, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Up to approximately 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2018.