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Head and Neck Squamous Cell CarcinomaPhase 2NCT03874741

SCT200 Plus Platinum-based Chemotherapy in Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing SCT200 in people with Head and Neck Squamous Cell Carcinoma, run by Sinocelltech Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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 evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
SCT200
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
21 May 2019to 1 Jul 2021
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

  • Voluntarily participate in this clinical trial and sign an informed consent form;
  • Male or female, age ≥ 18 and ≤ 75 years old;
  • ECOG fitness status score 0 to 1;
  • Recurrent and/or metastatic HNSCC (except nasopharyngeal carcinoma) diagnosed by pathology #
  • Not suitable for topical treatment. Patients with only recurrent disease (no metastasis) must have received radiotherapy (as post-operative adjuvant therapy or as a treatment for locally advanced HNSCC) as a "localized area treatment" and radiotherapy must be completed at least 6 months prior to screening imaging#
  • Laboratory inspection:
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  • Blood routine: neutrophils ≥1.5×l09/L, platelets≥75×109/L, hemoglobin≥80g/L;
  • Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ upper limit of normal value × 3 for liver metastasis, ALT and AST ≤ upper limit of normal value for liver metastases × 5; total bilirubin ( TBIL) ≤ upper limit of normal value × 2.0;
  • Renal function: creatinine (Cr) ≤ normal upper limit × 1.5;
  • Electrolyte: Magnesium ≥ normal lower limit;
  • According to the RECIST standard version 1.1, there is at least one measurable tumor lesion.

Who cannot join

  • Patients with a history of central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, imaging confirmation must be performed within 28 days prior to enrollment to exclude central nervous system metastasis;
  • Received systemic chemotherapy for advanced or metastatic HNSCC, but do not include induction chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy (the end of this treatment must be more than 6 months from the first trial);
  • There are other medical history of malignant tumors, except that the malignant lesions have been treated with therapeutic measures 5 years or more before enrollment and there are no known active lesions. The investigator judges that the risk of recurrence is low; Non-melanoma skin cancer, and no evidence of worsening disease; adequately treated cervical cancer in situ, and no evidence of worsening disease; prostatic intraepithelial neoplasia, no evidence of prostate cancer recurrence;
  • known to be allergic to antibodies or other components contained in the test drug;
  • have received EGFR antibodies (such as panitumumab, cetuximab or its analogs), or small molecule EGFR inhibitors (such as gefitinib, erlotinib, lapatinib, etc.);
  • In the 4 weeks or 4 weeks before enrollment, they received anti-tumor drugs (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) or received research drug treatment and could not be included in the evaluation by the investigator. Pain-free palliative radiotherapy for bones;
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  • At the time of enrollment, patients still had ≥2 peripheral neuropathy or hearing loss;
  • Patients have been enrolled in other study devices or study drug studies at screening time, or have been deactivated for less than or equal to 4 weeks from other study drugs or study devices;
  • Conduct or plan major surgery within 4 weeks prior to enrollment;
  • Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GMCSF) within 2 weeks prior to enrollment;
  • Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA]
  • ≥ II), uncontrollable severe arrhythmia);
  • Myocardial infarction occurred within 6 months prior to enrollment;
  • History of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
  • have clinical symptoms, require clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks;
  • medical or psychiatric history or laboratory abnormal medical history that may interfere with the interpretation of the results;
  • Patients who are pregnant or breast-feeding, or who plan to be pregnant during the treatment period and within 6 months after the end of treatment;
  • Patients (including male or female patients) who are unwilling to receive effective contraception during the treatment period and within 6 months after the end of treatment;
  • HCV antibody positive; or HIV positive; or HBV test results: HBsAg positive and / or HBcAb positive and HBV DNA ≥ 104 copy number or ≥ 2000 IU / ml;
  • Patients have active or uncontrollable infections (except for simple urinary tract infections or upper respiratory tract infections) requiring systemic treatment within 2 weeks or 2 weeks prior to enrollment;
  • known patients have alcohol or drug addiction;
  • The investigator believes that patients have other conditions that may affect their adherence to protocol adherence and study indicators, and are not suitable for patients participating in the study

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer hospital Chinese academy of medical sciences

    Beijing, Beijing Municipality

Other trials in China

About this study

Official title: A Phase II Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) and Standard Chemotherapy for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Read the detailed description

This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of first-line with anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

Being tested
SCT200
Keywords
Head and Neck Cancer, Epidermal growth factor receptor, SCT200
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

What participants receive

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

  • SCT200Drug

    Also called Anti-EGFR monoclonal antibody

    Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression

    Other Names:

    • SCT200
Study groups in NCT03874741
Study groupRoleWhat they receive
Arm - ExperimentalExperimentalAnti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
Receives: Drug: SCT200

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.

    Measured: 1 year

Secondary outcomes (6)

  1. Disease control rate (DCR)

    The achievement of any stable disease#SD#, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.

    Measured: 1 year

  2. Progresssion free survival(PFS)

    PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.

    Measured: 1 year

  3. Overall survival(OS)

    OS is defined as time from first dose of SCT200 until the date of death from any cause

    Measured: 1 year

  4. Immunogenicity

    Serum anti-SCT200 antibody levels before and after administration

    Measured: 1 year

  5. EORTC QLQ-C30

    Median scores for each item and domain will be reported at each time point. 30 items questionnaire with answers ranging from 1=not at all to 4=very much includes five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea \& vomiting and pain) and a global health status/QOL scale.

    Furthermore, it contains six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties)

    Measured: 1 year

  6. EORTC QLQ-H&N35

    European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H \& N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.

    Measured: 1 year

Timeline

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

  1. First posted14 Mar 2019
  2. Study start21 May 2019
  3. Primary completion30 Jun 2020 (estimated)
  4. Study completion1 Jul 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03874741
Sponsor's protocol ID
SCT200-B202
Status last verified
May 2020
First submitted
8 Mar 2019
Last updated
27 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 SCT200 in people with Head and Neck Squamous Cell Carcinoma, run by Sinocelltech Ltd. 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 11 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 27 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: 1 year). 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 NCT03874741.

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 27 May 2020.

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