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Head and Neck Squamous Cell CarcinomaPhase 2NCT04399785

Phase II Study for Combination of Camrelizumab and SBRT in the First-line Treatment for R/M HNSCC

A Phase 2 study testing Camrelizumab and SBRT in people with Head and Neck Squamous Cell Carcinoma, run by Xingchen Peng 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a prospective, single-center, open-label, phase II clinical study for patients with recurrent or metastatics quamous cell carcinoma of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Camrelizumab and SBRT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 Jun 2020to 1 Jun 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell carcinoma of the head and neck;
  • Patients with untreated recurrent or metastatic disease;
  • Combined positive Score>=1;
  • Aged >=18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • At least one measurable lesion, according to RECIST 1.1;
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  • Major organ functions within 28 days prior to treatment meet the following criteria(14 days without transfusion):
  • HB>=80g/L, ANC>=1.5x10^9/L, PLT >=80x10^9/L;
  • TBIL<=1.5 ULN, ALT and AST <=2.5 ULN, if there exists hepatic metastases, ALT and AST <=5 ULN, Cr <=1.5 ULN or CCr >=60ml/min;
  • INR or PT <= 1.5 ULN, APTT <=1.5 ULN (if the patient is receiving anticoagulant therapy, PT and APTT should be within the expected treatment range);
  • BNP <=ULN;
  • T3 <=ULN and T4 <=ULN after treatment;
  • Appropriate contraception should be used from the start of treatment to 120 days after the end of treatment; For female subjects with reproductive potential: a negative serum pregnancy test;
  • Have signed consent form.

Who cannot join

  • Have other malignant tumors in the past 5 years, except for cured in cured basal cell carcinoma, situ cervical carcinoma and thyroid papillary carcinoma ;
  • Known allergic reactions to the components of PD-1 monoclonal antibody;
  • Central nervous system metastasis with symptoms;
  • Treatment with a strong CYP3A4 inhibitor within 1 week or a strong inducer of CYP3A4 within 2 weeks.
  • Congestive heart failure of New York Heart Association (NYHA) Class III or IV;
  • Ischemic cardiovascular events occurred within 1 year prior to the start of treatment;
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  • ECG QT interval >500ms;
  • Patients are receiving immunosuppressive therapy;
  • Treatment with an immunotherapy, including anti-PD-1, anti-PD-L1 and anti-CTLA-4;
  • Treatment with an investigational agent within 4 weeks;
  • Treatment with oral or parenteral corticosteroids (>10mg per day) within 2 weeks or a requirement for chronic systemic immunosuppressive therapy;
  • Treatment with anti-tumor vaccine or live vaccines within 4 weeks
  • Surgery or severe trauma within 4 weeks;
  • Active infection;
  • Active autoimmune disease;
  • History of immunodeficiency, including HIV antibody positive, primary immunodeficiency, or the allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
  • History of noninfectious pneumonia;
  • Active tuberculosis within 1 year, or had a history of active tuberculosis infection one year ago but did not receive standard treatment;
  • Active hepatitis, including HBV DNA ≥ 2000IU/ml or 10 ⁴ copies / ml or HCV antibody and HCV-RNA positive;
  • History of alcoholism and drug abuse;
  • Patients with symptoms of gastrointestinal bleeding or risk of bleeding;
  • Patients are pregnant or breast-feeding;
  • Any other condition or circumstance that could interfere with adherence to the study's procedures or requirements, or otherwise compromise the study's objectives.

Trial locations and contacts

1 site in 1 country.

Xingchen Peng, Dr contact

+86 18980606753

pxx2014@scu.edu.cn

Yan Li, Dr contact

+862885422591

yy1240@163.com

China1 site, 1 recruiting

  • Xingchen Peng

    Chengdu, Sichuan, 610041

    Xingchen Peng, +86 18980606753, pxx2014@scu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Phase II Study for Combination of Camrelizumab and Stereotacic Radiotherapy in the First-line Treatment for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

This study is a prospective, single-center, open-label, phase II clinical study for patients with recurrent or metastatics quamous cell carcinoma of the head and neck.

Being tested
Camrelizumab and SBRT
Keywords
Anti-PD-1 Inhibitor, Stereotacic Radiotherapy, Head and Neck Squamous Cell Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • Camrelizumab and SBRTOther

    Camrelizumab: 200mg every 3 weeks; SBRT

Study groups in NCT04399785
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Other: Camrelizumab and SBRT

What is being measured

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

  1. ORR

    Objective Response Rate

    Measured: up to approximately 2 years

Secondary outcomes (4)

  1. PFS

    Progression-Free-Survival

    Measured: up to approximately 2 years

  2. OS

    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

    Measured: up to approximately 2 years

  3. DOR

    Disease Control Rate

    Measured: up to approximately 2 years

  4. AE

    Adverse Events

    Measured: from the first drug administration to within 30 days for the last therapy

Timeline

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

  1. First posted22 May 2020
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion1 Dec 2021 (estimated)
  4. Study completion1 Jun 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Combination of camrelizumab and stereotacic radiotherapy
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04399785
Sponsor's protocol ID
CART0326
Status last verified
May 2020
First submitted
16 May 2020
Last updated
22 May 2020
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 Camrelizumab and SBRT in people with Head and Neck Squamous Cell Carcinoma, run by Xingchen Peng 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 14 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 22 May 2020. 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 Xingchen Peng, Dr (+86 18980606753, pxx2014@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: up to approximately 2 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 NCT04399785.

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 May 2020.

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