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HCCPhase 2NCT04165174

PD-1 Monoclonal Antibody Plus Apatinib Combined With SBRT in HCC With PVTT

A Phase 2 study testing Terepril monoclonal antibody; Apatinib and SBRT in people with HCC, run by Huazhong University of Science and Technology at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

It is a trial to assess the efficacy and safety of PD-1 monoclonal antibody plus Apatinib combined with SBRT as first-line treatment in HCC with PVTT. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HCC
What is being tested?
Terepril monoclonal antibody; Apatinib and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
Dec 2019to Dec 2020
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 2. Patients with primary hepatocellular carcinoma confirmed by cell or histopathology were complicated with PVTT and BCLC stage C.
  • 3. According to RECIST criteria, there is at least one measurable lesion, which is a lesion other than SBRT.
  • 4. Child-Pugh A or partial B grade of liver function (recovered to A grade after supportive treatment); normal liver volume > 700 ml;
  • 5. Renal function: Serum creatinine < 1.5 times normal upper limit;
  • 6. ECOG score 0-1;
  • 7. The life expectancy is more than 3 months.
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  • 8. There were no obvious signs of hematological diseases, ANC (> 1.5 109/L), platelet count (> 75 109/L) and no tendency of bleeding before enrollment, HGB (> 90 g/L) and INR (< 2.5 times normal upper limit and APT (< 1.5 times normal upper limit).
  • 9. FT3, FT4 and TSH are within the normal range of 10%.
  • 10. No history of abdominal irradiation.
  • 11. Patients with other previous malignant tumors had a disease-free survival of more than 2 years after initial treatment (e.g. non-melanoma skin cancer or cervical cancer in situ).
  • 12. The patient signed the informed consent.
  • 13. Female patients of childbearing age or male patients whose sexual partners are women of childbearing age need to take effective contraceptive measures during the whole treatment period and within 6 months after treatment.
  • 14.It is better to provide tissue samples for biomarker analysis (e.g. PD-L1) and to optimize newly acquired tissues. Patients who are unable to provide newly acquired tissues can provide 5-8 paraffin sections of 3-5 micron thickness for archival preservation.
  • -
  • Exclusion Criteria:1. Fibrous layer hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma and mixed hepatocellular carcinoma;
  • 2. History of hepatic encephalopathy or liver transplantation;
  • 3. Pleural effusion, ascites and pericardial effusion with clinical symptoms or needing drainage. Only a small amount of pleural effusion, ascites and pericardial effusion, asymptomatic;
  • 4. Untreated hepatitis infection: HBV DNA > 2000iu/ml, HCV RNA > 103copy/ml, HBsAg and anti-HCV antibodies were positive.
  • 5. Distant metastasis.
  • 6. In the past six months, there have been history of gastrointestinal perforation and/or fistula, intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), inflammatory bowel disease or extensive intestinal resection (partial or extensive enterectomy for chronic diarrhea), Crohn's disease, ulcer, etc. Acute colitis or chronic diarrhea;
  • 7. Symptomatic history of interstitial lung disease or other conditions that may lead to confusion in the detection or management of suspected drug-related pulmonary toxicity;
  • 8. Evidence of active pulmonary tuberculosis (TB). Patients diagnosed with active pulmonary tuberculosis infection within one year should be excluded even if they have received treatment.
  • 9. Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) positive;
  • 10. Severe infections are active or under clinical control. Severe infections occurred within 4 weeks before the first treatment, including but not limited to hospitalization due to infections, bacteremia or complications of severe pneumonia.
  • 11. Patients with active, known or suspected autoimmune diseases. Patients with vitiligo, type I diabetes mellitus, thyroid dysfunction caused by autoimmune thyroiditis (only hormone replacement therapy) or diseases that do not recur without external stimuli can be selected.
  • 12. Immunosuppressive drugs used in the past four weeks, excluding local or systemic glucocorticoids (i.e., prednisone or other equivalent doses of glucocorticoids not exceeding 10 mg/day), through nasal sprays, inhalation or other routes, and temporarily using glucocorticoids to treat dyspnea symptoms of asthma, Chronic obstructive pulmonary disease;
  • 13. Any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) have been vaccinated in the past four weeks.
  • 14. Receiving systemic immune stimulation therapy in the past four weeks;
  • 15. In the past four weeks, major operations (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures have been performed.
  • Uncontrolled metabolic disorders or other non-malignant organs or systemic diseases or secondary tumors may lead to higher medical risks and/or uncertainty in survival assessment;
  • 17. Laboratory test values for some acute or chronic diseases, psychiatric disorders or abnormalities that may lead to outcomes: increased risk of participating in research or drug management, or interference with the interpretation of research results, according to the judgement of researchers, patients are classified as not eligible to participate in research;
  • 18. Other malignant tumors were diagnosed within five years before the first administration, excluding cured basal cell carcinoma of the skin, cured squamous cell carcinoma and/or in situ cured cancer. If other malignant tumors or hepatocellular carcinomas are diagnosed more than 5 years before administration, pathological or cytological diagnosis should be made from the sites of recurrence and metastasis.
  • 19. Use anti-PD-1/PD-L1/PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) for any prior immunosuppressive treatment.
  • 20. Patients with known sensitivity or allergy to any component of humanized anti-PD-1 antibody or Apatinib;
  • 21. Pregnancy and breastfeeding.
  • -

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Xianglin Yuan, MD,PhD contact

8627-83663406

xlyuan1020@163.com

Yanmei Zou, MD,PhD contact

8627-83663406

zouyanmei0101@126.com

China1 site, 1 recruiting

  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430000

    Xianglin Yuan, PhD,MD, 8627-83663406, xlyuan1020@163.com

    Yanmei Zou, PhD,MD, 8627-83663406, zouyanmei0101@126.com

    Recruiting

Other trials in China

About this study

Official title: A Single Arm, Observational Clinical Trial to Evaluate the Efficacy and Safety of Combination Treatment With PD-1 Monoclonal Antibody Plus Apatinib and SBRT in HCC With PVTT

It is a trial to assess the efficacy and safety of PD-1 monoclonal antibody plus Apatinib combined with SBRT as first-line treatment in HCC with PVTT.

Conditions
HCC
Being tested
Terepril monoclonal antibody; Apatinib, SBRT
Keywords
HCC, PVTT, PD-1, Apatinib, SBRT

What participants receive

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

  • Terepril monoclonal antibody; ApatinibDrug

    Terepril monoclonal antibody,240mg,ivdrip,Q3W Apatinib,250mg,po,QD

  • SBRTRadiation

    6-10Gy/F,5-8F

Study groups in NCT04165174
Study groupRoleWhat they receive
PASExperimentalPD-1:240mg,ivdrip,Q3W,begin with SBRT Apatinib:250mg,po,QD,begin with SBRT SBRT:6-10Gy/F,5-8F
Receives: Drug: Terepril monoclonal antibody; Apatinib; Radiation: SBRT

What is being measured

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

  1. PFS

    PFS is defined as time from the start of treatment to progression of disease or death.

    Measured: up to 3 years

Secondary outcomes (5)

  1. OS

    Overall survival is defined as time from the start of treatment until death due to any reason.

    Measured: up to 3 years

  2. ORR

    The rate of participants that achieve either a complete response (CR) or a partial response (PR).

    Measured: up to 3 years

  3. DCR

    The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.

    Measured: up to 3 years

  4. TTSP

    The time between the onset of randomized grouping and the onset of symptomatic progression.

    Measured: up to 3 years

  5. Safety as measured by number and grade of adverse events

    Summary adverse events according to NCI-CTCAE 4.03

    Measured: up to 3 years

Timeline

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

  1. First posted15 Nov 2019
  2. Study startDec 2019 (estimated)
  3. Primary completionNov 2020 (estimated)
  4. Study completionDec 2020 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04165174
Sponsor's protocol ID
TJCC 010
Status last verified
Nov 2019
First submitted
1 Oct 2019
Last updated
15 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Terepril monoclonal antibody; Apatinib and SBRT in people with HCC, run by Huazhong University of Science and Technology 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 36 inclusion and 0 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 15 Nov 2019. 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 Xianglin Yuan, MD,PhD (8627-83663406, xlyuan1020@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: up to 3 years). 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 NCT04165174.

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 15 Nov 2019.

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