Study of PolyIC and PD-1 mAb in Subjects With Unresectable Hepatocellular Carcinoma

NCT03732547 | Unknown Phase 2 DMC

• 1 other identifier: CISLD-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma; Polyinosinic-polycytidylic acid; PD-1 mAb

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Percentage of patients whose cancer shrinks or disappears after treatment

  Up to approximately 5 years

Secondary Outcomes (6)

• Disease control rate (DCR)

  Up to approximately 5 years

• Progression free survival (PFS)

  Up to approximately 5 years

• Overall survival (OS)

  Up to approximately 5 years

• Number of participants with treatment-related adverse events

  Up to approximately 5 years

• Percentage of participants with a better life quality

  Up to approximately 5 years

Study Arms (1)

'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.

Drug: PD-1 mAb; Drug: PolyIC

Interventions

PD-1 mAb DRUG

Intravenous infusion of PD-1 mAb, 200mg, once a time, every three weeks.

Also known as: Programmed cell death-1 monoclonal antibody

'PolyIC plus PD-1 mAb' and 'PD-1 mAb'

PolyIC DRUG

Intramuscular injection of polyIC, 2mg, every other day, for three weeks.

Also known as: Polyinosinic-polycytidylic acid

'PolyIC plus PD-1 mAb' and 'PD-1 mAb'

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Poly I-C

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Poly C; Polyribonucleotides; Polynucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Poly I

Study Officials

• Tingbo Liang, MD PhD

  second affiliated hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingbo Liang, MD PhD

CONTACT

+8615088682641; liangtingbo@zju.edu.cn

Liang Wen, MD PhD

CONTACT

+8619967413613; 11518214@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: November 6, 2018
• Study Start: October 22, 2018
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2023
• Last Updated: November 16, 2018

Record last verified: 2018-10

Locations

CN (1)