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Gastric CancerPhase 1/2NCT02942329

Exploratory Clinical Study of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric Cancer

A Phase 1/2 study testing apatinib and SHR-1210 in people with Gastric Cancer and Hepatocellular Carcinoma, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or gastric cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gastric Cancer, Hepatocellular Carcinoma
What is being tested?
apatinib and SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
Oct 2016to Oct 2018
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70 years old, both genders.
  • To be confirmed to meet the clinical diagnosis standard, histologically or cytologically confirmed with hepatocellular carcinoma or gastric cancer. Patients must be diagnosed with advanced disease(not eligible for surgical and/or locoregional therapies, or metastatic disease), disease progressed or refractory to standard therapies(had been intolerant to standard therapies, or had refused standard therapy), or lack of other effective treatment methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
  • Life expectancy of at least 3 months.
  • Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria.
  • For patients with advanced hepatocellular carcinoma, liver function status Child-Pugh Class A or B (score<=7).
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  • Patients must have adequate organ function (without blood transfusion, without growth factor or blood components support within 14 days before enrollment)as determined by: Hemoglobin ≥ 9 g/dL; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet count ≥ 75×109/L (for patients with advanced hepatocellular carcinoma), Platelet count ≥ 100×109/L (for patients with advanced gastric cancer); serum albumin ≥2.8 g/dL; serum total bilirubin (TBIL)≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×upper limit of normal(ULN), for subjects with liver metastases, ALT and AST≤5×ULN; Calculated creatinine clearance (CrCl) > 50 mL/min (Cockcroft-Gault formula will be used to calculate CrCl).
  • Females of childbearing potential (FOCBP), who are not surgically sterile or postmenopausal, must conduct pregnancy test (serum or urine) within 7 days before enrollment, and must not be pregnant or breast-feeding women. If the result is negative, she must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs. And non-sterilized males who are sexually active must agree to use adequate contraception during the experiment and 3 months after the last administration of the test drugs.
  • Patients join the study voluntarily, sign a consent form, have good compliance, and comply with follow-up.

Who cannot join

  • Patients must not have had prior treatment with SHR-1210 or any other PD-L1 or PD-1 antagonists, 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 other antibody formulation.
  • 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).
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  • 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).
  • Previous experience abdomen fistula, gastrointestinal perforation, or abdominal abscess within 4weeks.
  • 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

1 site in 1 country.

Jian-Ming Xu, M.D. contact

+861066947176

jmxu2003@yahoo.com

China1 site, 1 recruiting

  • The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

    Beijing, Beijing Municipality, 100071

    Jian-Ming Xu, M.D., +861066947176, jmxu2003@yahoo.com

    Jian-Ming Xu, M.D.

    Recruiting

Other trials in China

About this study

Official title: Exploratory Clinical Study of the Combination of Apatinib and SHR-1210 in Treating Advanced Hepatocellular Carcinoma or Gastric Cancer

The purpose of this study is to observe and preliminary explore the efficacy and safety of combination of Apatinib and SHR-1210 regimen in treating advanced hepatocellular carcinoma or gastric cancer.

Apatinib is a small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.

SHR-1210 is a humanized anti-PD-1 monoclonal antibody.

Read the detailed description

Patients will received apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks. The efficacy and safety will be observed.

The dose escalation phase has completed for apatinib from 125mg, 250mg to 500mg. The dose of 250mg showed best tolerance and efficacy especially in hepatocellular carcinoma. Thus, for hepatocellular carcinoma patients, apatinib 250mg orally every day was chosed for the dose extension phase. In gastric cancer, the dose of 250mg also showed good tolerance but mild efficacy. Thus, for gastric cancer patients, the dose of 375mg daily for apatinib would be explored and then the investigators will decide the best dosage for these patients.

Being tested
apatinib, SHR-1210
Keywords
humanized anti-PD-1 monoclonal antibody, apatinib, Gastric Neoplasms, Gastric Cancer, Cancer of Stomach, Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Cell Carcinoma
Medical subject headings
Stomach Neoplasms, Carcinoma, Hepatocellular

What participants receive

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

  • apatinibDrug

    Apatinib was administered 250mg or 375mg orally daily. For gastric cancer patients, the dose would be 250mg or 375mg daily. For hepatocellular carcinoma patients, the dose would be 250mg daily.

  • SHR-1210Drug

    SHR-1210 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.

Study groups in NCT02942329
Study groupRoleWhat they receive
apatinib and SHR-1210ExperimentalEvery patients will received apatinib orally every day and SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks until disease progression or intolerance of side effects.
Receives: Drug: apatinib; Drug: SHR-1210

What is being measured

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

  1. Overall survival rate

    6 months and 12 months

    Measured: Up to approximately 12 months

Secondary outcomes (4)

  1. Tumor response rate

    Measured: Up to approximately 12 months

  2. Disease control rate

    Measured: Up to approximately 12 months

  3. Duration of response

    Measured: Up to approximately 12 months

  4. Safety as measured by the rate of AEs, deaths and laboratory abnormalities (e.g. Grade 3 or higher per CTCAE v4 )

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

Timeline

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

  1. First posted24 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2018 (estimated)
  4. Study completionOct 2018 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02942329
Sponsor's protocol ID
SHR-1210-APA-01
Status last verified
Jan 2018
First submitted
20 Oct 2016
Last updated
26 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Xu J, Zhang Y, Jia R, Yue C, Chang L, Liu R, Zhang G, Zhao C, Zhang Y, Chen C, Wang Y, Yi X, Hu Z, Zou J, Wang Q. Anti-PD-1 Antibody SHR-1210 Combined with Apatinib for Advanced Hepatocellular Carcinoma, Gastric, or Esophagogastric Junction Cancer: An Open-label, Dose Escalation and Expansion Study. Clin Cancer Res. 2019 Jan 15;25(2):515-523. doi: 10.1158/1078-0432.CCR-18-2484. Epub 2018 Oct 22.

    PubMed 30348638

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing apatinib and SHR-1210 in people with Gastric Cancer and Hepatocellular Carcinoma, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences 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 9 inclusion and 23 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 26 Feb 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 combined 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.

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 Jian-Ming Xu, M.D. (+861066947176, jmxu2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: Up to approximately 12 months). 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 NCT02942329, which also lists 1 linked publication.

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 26 Feb 2018.

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