AzTrials
AzTrials

Advanced/Metastatic Hepatocellular CarcinomaPhase 1NCT04665362

IIT Study of M1-c6v1 Combined With SHR-1210 and Apatinib in Patients With HCC

A Phase 1 study testing Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib in people with Advanced/Metastatic Hepatocellular Carcinoma, run by Liang Peng.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 （M1-c6v1）(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
25 Jan 2021to 30 Oct 2022
Phase
Phase 1
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-65 years old, both genders.
  • To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed with hepatocellular carcinoma
  • Life expectancy of at least 3 months.
  • Patients was not received any systemic therapies to HCC.
  • For patients with advanced hepatocellular carcinoma, liver function status Child-Pugh Class A or B (score<=7).
  • HCC staging is evaluated according to Diagnostic and therapeutic criteria for liver cancer (2019 Edition, National health commission, P.R.A)
Show all 17Show fewer
  • a: with vascular invasion and no extrahepatic metastasis, no matter the tumor condition; Child-Pugh A/B；PS 0~2.
  • b: with extrahepatic metastasis, no matter the tumor condition and vascular invasion; Child-Pugh A/B；PS 0~2, not eligible for surgical and/or locoregional therapies.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
  • Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria (The long diameter of the lesion on spiral CT scan was more than or equal to 10 mm or the short diameter of enlarged lymph node was more than or equal to 15 mm).
  • Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by:
  • ① Blood system: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L.
  • ② Liver function: Serum total bilirubin (TBIL)≤2 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤5×upper limit of normal(ULN), Serum albumin ≥ 28 g/L; Alkaline phosphatase(ALP) ≤5×ULN;
  • ③ Kidney function: Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl); Creatinine (Cr) ≤ 1.5×ULN; Urine protein <2+ or Baseline of urine protein ≥ 2+ and 24h urinary protein quantity ≤ 1g.
  • ④ Coagulation function: International Normalized Ratio (INR) or Activated partial thromboplastin time (APTT) ≤ 1.5×ULN
  • Reproductive subjects (male and female) must agree to use effective birth control measures with their partners for at least 180 days after the last medication.
  • Volunteer to participate in clinical research; fully understand and be able to sign the informed consent form (ICF); willing to follow and have the ability to complete all trial procedures.

Who cannot join

  • Patients must not have had prior treatment with SHR-1210 or any other PD-L1 or PD-1 antagonists or any other oncolytic virus, and must not have had be enrolled in the phase III Study of Apatinib After Systemic Therapy in Patients With Hepatocellular Carcinoma.
  • Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
  • Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration. Note: corticosteroids used for the purpose of IV contrast allergy prophylaxis are allowed.
  • Known history of hypersensitivity to any components of the SHR-1210 formulation, or M1-c6v1 (mannitol, human albumin, trehalose).
  • Active central nervous system (CNS) metastases with clinical symptoms (including cerebral edema, steroid requirement, or progressive disease). Subjects with brain or meningeal metastases that were previously treated must be clinically stable (magnetic resonance imaging [MRI] at least 4 weeks apart do not show evidence of new or enlarging metastases) and have discontinued immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for at least 2 weeks before study drug administration.
  • Patients with other malignant tumor (except cured skin basal cell carcinoma and cervical carcinoma).
Show all 22Show fewer
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, or coronary artery bypass surgery, Congestive heart failure (New York heart association (NYHA) class > 2), ventricular arrhythmia which need medical intervention, left ventricular ejection fraction(LVEF) < 50%.
  • Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents(within 3 months): systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg.
  • Coagulation abnormalities (PT>16s、APTT>43s、TT>21s、Fbg<2g/L), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
  • Prior systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, surgery or target therapy within 4 weeks (Or 5 half-life of the drug, calculate the longer ) before the study drug administration, or any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (with the exception of any stable chronic toxicities not expected to resolve).
  • Patients with clinical symptoms of ascites or pleural effusion, need therapeutic puncture and drainage.
  • Previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency, such as: esophageal varices, local active ulcerative lesions, gastric ulcer and duodenal ulcer, the ulcerous colitis, gastrointestinal diseases such as portal hypertension or resection of tumor with bleeding risk, etc.
  • Patients with or previous with serious hemorrhage (bleeding > 30 ml within 3 months), haemoptysis (> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).
  • Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled).
  • Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, pulmonary function damaged seriously etc.
  • History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or active hepatitis (transaminase does not meet the inclusion, hepatitis B virus (HBV) DNA ≥10⁴ /ml or hepatitis C virus (HCV) RNA≥103 /ml or higher); Chronic hepatitis B virus carriers who HBV DNA<2000 IU/ml(<104/ml), must receive anti-viral treatment throughout the study.
  • Participated in other clinical trials, or finish other clinical trials within 4 weeks.
  • Patients who may receive other anti-tumor systemic chemotherapy during the study.
  • Patients who has bone metastasis, have received Palliative radiotherapy (radiotherapy area > 5% marrow area).
  • Patients who may receive vaccination during the study, or previous had vaccination within 4 weeks.
  • Mental disorders history, or psychotropic drug abuse history.
  • Any other medical, psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare, or ability to sign informed consent, cooperate, and participate in the study or would interfere with the interpretation of the results.

Trial locations and contacts

No sites are listed yet.

Liang Peng, MD contact

8613533978874

pliang@mail.sysu.edu.cn

About this study

Official title: A Single-arm Study to Evaluate the Safety and Efficacy of Recombinant Oncolytic Virus M1 (M1-c6v1) Combined With Anti-PD-1 Antibody SHR-1210 and Apatinib for Treatment of Patients With Advanced / Metastatic Hepatocellular Carcinoma

This is a single arm and open-label phase I trial to evaluate the safety, tolerability and efficacy of the oncolytic virus M1 （M1-c6v1）(iv 1×109 CCIC50, 1 dose per day, on day 1-5 each 28 day cycle) combined with anti-PD-1 antibody SHR-1201 (iv, 200 mg, once every two weeks) and Apatinib (po. 250 mg qd ) in the patients with advanced/metastatic hepatocellular carcinoma. 10 participants will be sequentially enrolled. The treatment duration is 12 months. All patients continue combination treatment until disease progression, unacceptable toxicity, death, or discontinuation for any reason.

Being tested
Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Recombinant oncolytic virus M1, anti PD-1 antibody, ApatinibDrug

    Drug: Recombinant oncolytic virus M1

    Recombinant oncolytic virus M1 is administered intravenously 1×109 CCIC50 once daily on day1-5, every 28 day cyle.

    Other name：M1-c6v1

    Drug：Anti-PD-1 antibody

    Anti-PD-1 antibody is administered intravenously 200 mg once every 2 weeks.

    Other names：SHR-1210, Camrelizumab

    Drug: Apatinib

    Apatinib is administered orally 250mg once daily.

    Other name: Apatinib

Study groups in NCT04665362
Study groupRoleWhat they receive
M1-c6v1 combined with SHR-1210 and ApatinibExperimentalSingle-arm
Receives: Drug: Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment related adverse events

    Safety as measured by the rate of TRAEs according to NCI CTCAE v5.0

    Measured: From the first assignment of informed consent form up to 90 days after the last dose

Secondary outcomes (4)

  1. Overall response rate

    Measured: through study completion, an average of 1 year.

  2. Disease control rate

    Measured: through study completion, an average of 1 year.

  3. Overall survival

    6 month and 12 month OS rates

    Measured: Up to approximately 12 months after treatment

  4. Progression free survival

    6 month and 9 month PFS rates

    Measured: Up to approximately 9 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start25 Jan 2021 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion30 Oct 2022 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665362
Sponsor's protocol ID
VRT106-C02
Status last verified
Jan 2021
First submitted
1 Dec 2020
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib in people with Advanced/Metastatic Hepatocellular Carcinoma, run by Liang Peng.

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 17 inclusion and 22 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 22 Jan 2021. 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 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.

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 Liang Peng, MD (8613533978874, pliang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment related adverse events (time frame: From the first assignment of informed consent form up to 90 days after the last dose). 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 NCT04665362.

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 22 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in