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Lung DiseasesPhase 1/2NCT04133337

Apatinib Combined With SHR-1210 Injection in the Treatment of Patients With Removable IB-IIIA NSCLC

A Phase 1/2 study testing Apatinib and SHR-1210 in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute 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 The sponsor has not verified this record for over two years, so it may be out of date.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 aim of this study was to investigate the safety and efficacy of SHR-1210 in combination with the anti-vascular survival target drug apatinib in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with the period IB-IIIA NSCLC. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Apatinib and SHR-1210
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Nov 2019to Jun 2021
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age: 18 years old to 75 years old, male or female;
  • 2. Initial treatment of patients with IB-IIIA non-small cell lung cancer who are expected to be surgically resected;
  • 3. Histopathologically confirmed non-small cell lung cancer with measurable tumor lesions (spiral CT scan≥10mm, meeting RECIST 1.1 criteria);
  • 4. ECOG PS: 0-1 points
  • 5. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed for 2 weeks before the start of study): Absolute neutrophil count (ANC)≥1.5×10 E+9/L; platelets≥100×10E+9/L / L; hemoglobin ≥9g/dL; serum albumin(ALB)≥2.8g/dL; a total bilirubin (TBil) of≤1.5 ULN, ALT and AST≤2.5 ULN, in case of liver metastasis, ALT and AST≤5 ULN; creatinine clearance rate≥ 50mL/min(Cockcroft-Gault);thyroid function is normal.
  • 6. Estimated survival time≥3 months;
  • 7. Female subjects with fertility should undergo a urine or serum pregnancy test within 72 hours prior to the first study drug administration and are shown to be negative ,and willing to be 3 months after the last dose of SHR-1210 injection during the trial period. The effective method was used for contraception (from the control group to 180 days after the last administration). For male subjects whose partners are women of childbearing age, effective methods should be used during the test period and within 3 months after the last administration of SHR-1210 injection (control group to 180 days after the last administration);
  • 8. Patients were voluntarily enrolled in the study and signed an informed consent form (ICF) with good adherence and follow-up.

Who cannot join

  • 1. The patient has any active autoimmune disease or a history of autoimmune disease;
  • 2.The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose>10 mg / day of prednisone or other therapeutic hormones);
  • 3.Interstitial pneumonia ;
  • 4.Severe allergic reactions to other monoclonal antibodies ;
  • 5.Suffering from high blood pressure and not being well controlled by antihypertensive medication (systolic blood pressure≥140 mmHg or diastolic blood pressure≥90 mmHg) ;
  • 6.Have clinical symptoms or disease that are not well controlled ;
Show all 13Show fewer
  • 7.Abnormal coagulation function (INR>2.0, PT>16s), bleeding tendency or receiving thrombolysis or anticoagulant therapy, allowing prophylactic use of low-dose aspirin, low molecular weight heparin;
  • 8.There was significant coughing blood in the first 2 months before enrollment, or daily hemoptysis amounted to 2.5ml or more;
  • 9.Significant clinically significant bleeding symptoms or a clear tendency to hemorrhage during the first 3 months of randomization;
  • 10.Urinary routine suggests urinary protein≥ ++ and confirmed 24-hour urine protein> 1.0 g ;
  • 11.The patient has active infection, unexplained fever within 3 days before administration, ≥38.5 °C, or baseline white blood cell count>15×109/L;
  • 12.The patient has previously received other PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1;
  • 13.Other patients considered by the treating physician not suitable for inclusion .

Trial locations and contacts

1 site in 1 country.

Juan Li, MD contact

+8613880276636

dr.lijuan@gmail.com

China1 site

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Juan Li, MD, +8613880276636, dr.lijuan@gmail.com

Other trials in China

About this study

Official title: One-arm Exploratory Study on the Efficacy and Safety of Apatinib Combined With SHR-1210 Injection (PD-1 Antibody) in the Treatment of Removable IB-IIIA Non-small Cell Lung Cancer

The aim of this study was to investigate the safety and efficacy of SHR-1210 in combination with the anti-vascular survival target drug apatinib in patients with resectable NSCLC, and to provide new treatment options for neoadjuvant therapy in patients with the period IB-IIIA NSCLC.

Being tested
Apatinib, SHR-1210
Keywords
Apatinib, SHR-1210, NSCLC, neoadjuvant
Medical subject headings
Lung Diseases, Neoplasms, Respiratory Tract Diseases, Thoracic Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • ApatinibDrug

    Also called AiTan, H20140103

    Apatinib Mesylate Tablets

  • SHR-1210Drug

    Also called Camrelizumab, Karuilizhu Dankang, S20190027

    Camrelizumab for Injection

Study groups in NCT04133337
Study groupRoleWhat they receive
Apatinib Combined With SHR-1210 InjectionExperimental* Drugs:Apatinib Apatinib mesylate tablets 250 mg qd po, discontinued one week before surgery. * Drugs: SHR-1210 SHR-1210 injection 200mg (5mL), ivgtt, q2w, 3 cycles, each time 20-60min completed infusion. * Surgery: The patient underwent imaging examinations within 7 days prior to surgery, including chest CT and related metastatic examinations. The patient underwent surgery 7-8 weeks after the first dose.
Receives: Drug: Apatinib; Drug: SHR-1210

What is being measured

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

  1. Major pathologic response rate(MPR)(<10% viable tumor cells)

    To assess the major pathologic response rate (<10% viable tumor cells) in patients receiving Apatinib Combined With SHR-1210 Injection.

    Measured: At time of surgery

Secondary outcomes (3)

  1. Disease Control Rate (DCR)

    the proportion of patients with a best overall response of CR, PR or SD in the whole body, as assessed per RECIST 1.1 by the investigator.

    Measured: up to 2 years

  2. Overall response rate (ORR)

    the proportion of patients with a best overall confirmed response of CR or PR in the whole body as assessed per RECIST 1.1 by the investigator

    Measured: up to 2 years

  3. Disease-free survival (DFS)

    Defined as the time from date of surgery until recurrence of tumor or death from any cause

    Measured: up to 2 years

Timeline

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

  1. First posted21 Oct 2019
  2. Study start1 Nov 2019 (estimated)
  3. Primary completion1 Jun 2020 (estimated)
  4. Study completionJun 2021 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04133337
Sponsor's protocol ID
HR-SHR-NSCLC201906
Status last verified
Oct 2019
First submitted
17 Oct 2019
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Apatinib and SHR-1210 in people with Lung Diseases and Neoplasms, run by Sichuan Cancer Hospital and Research Institute 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 8 inclusion and 13 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 21 Oct 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 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 Juan Li, MD (+8613880276636, dr.lijuan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response rate(MPR)(<10% viable tumor cells) (time frame: At time of surgery). 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 NCT04133337.

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 21 Oct 2019.

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