AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 1/2NCT03817567

Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma

A Phase 1/2 study testing recombinant anti-EGFR monoclonal antibody in people with Esophageal Squamous Cell Carcinoma, run by Sinocelltech Ltd. at 4 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
recombinant anti-EGFR monoclonal antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
4 sitesChina
Study dates
17 Jul 2018to 31 May 2020
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

  • Males or females. Aged 18 to 75 years old;
  • Histologically or cytologically proven squamous cell carcinoma of the esophagus, which is locally unresectable or distant metastatic disease;
  • Disease progressed following standard therapies. Patients has treated with taxane/platinum/fluorouracil and/or radiotherapy. Failure of standard therapy ：Disease progressed or developed non-tolerable toxicity during or within 3 months after last systemic chemotherapy or radical concurrent chemoradiotherapy. For adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy;
  • According to RECIST 1.1 , patients must have at least one measurable lesion which was not treated with local treatment such as radiotherapy. Tumour lesions situated in a previously irradiated area which have been demonstrated progression in the lesion, are considered measurable;
  • With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
  • Life expectancy of longer than 3 months ( clinical assessment);
Show all 10Show fewer
  • Adequate organ and marrow function as defined below:
  • Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to 5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN; Electrolyte: magnesium greater than/equal to normal.
  • Women of childbearing potential must not be pregnant as assessed by a negative urine or serum beta HCG test upon admission to the hospital, and must agree to use adequate contraception during the study until to 6 months after the last dose of SCT200.For male,if his sexual partners is child-bearing potential, he should use effective contraception from the time of signing the informed consent form until at least 6 months after the last dose of study drug.
  • Able to provide written informed consent and can understand and comply with the requirements of the study;

Who cannot join

  • Patients with active central nervous system metastasis or a history of central nervous system metastasis;(If the subject has been suspected with central nervous system metastasis,imaging examination confirmation must be performed within 28 days to exclude central nervous system metastasis;
  • Patients with other primary malignancies except cured of non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia;
  • Patients who are allergic to analogue of SCT200 and/or its inactive ingredients;
  • Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR monoclonal antibody;
  • Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);
  • Patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices;
Show all 17Show fewer
  • Patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery;
  • Patients treated with EPO, G-CSF or GM-CSF;
  • Patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable severe arrhythmia);
  • Patients occurred myocardial infarction within 6 months;
  • Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or CT or MRI reminder ILD ;
  • Patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites);
  • Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV antibody positive (if there is no clinical evidence suggesting that there may be HIV infection, there is no need to detect);
  • Patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection);
  • Patients have alcohol or drug addiction;
  • Patients with serious abnormal medical, psychological or laboratory results history which may affect explanation of study results;
  • Subjects are considered not suitable for the study by investigator,who have other conditions that may affect their adherence and the evaluation of study indicators.,

Trial locations and contacts

4 sites in 1 country.

Foxiao Qiao, Ph D contact

18911165421 ext. 86-10-58628288

Foxiao_qiao@sinocelltech.com

China4 sites, 4 recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin

    wei li, MD

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    yuxian bai, MD

    Recruiting

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality

    yi ba, MD

    Recruiting

  • Henan Cancer Hospital.

    Zhengzhou, Henan

    kai zang, MD

    Recruiting

Other trials in China

About this study

Official title: Phase Ib, Open-label, Single-arm, Multicenter Study to Evaluate Safety and Efficacy of SCT200 in Patients With Advanced Esophageal Squamous Cell Carcinoma Progressed Following Treatment With Taxane/Platinum/Fluorouracil

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR monoclonal antibody（SCT200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil.

Read the detailed description

This is a open label, single-arm multicenter phase Ib study,and is designed to evaluate Objective Response Rate (ORR) in advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil treated with anti-EGFR monoclonal antibody SCT200.

Being tested
recombinant anti-EGFR monoclonal antibody
Keywords
Carcinoma, Carcinoma, Squamous Cell, Esophageal Neoplasms, Neoplasms, Squamous Cell, Esophageal Diseases, Epidermal growth factor receptor, EGFR, SCT200
Medical subject headings
Esophageal Squamous Cell Carcinoma, Carcinoma, Carcinoma, Squamous Cell, Esophageal Neoplasms, Neoplasms, Squamous Cell, Esophageal Diseases

What participants receive

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

  • recombinant anti-EGFR monoclonal antibodyDrug

    Also called SCT200

    Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.

Study groups in NCT03817567
Study groupRoleWhat they receive
recombinant anti-EGFR monoclonal antibody（SCT200）Experimental6.0mg/kg QW for 6 weeks, then 8.0mg/kg Q2W
Receives: Drug: recombinant anti-EGFR monoclonal antibody

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: one year

Secondary outcomes (4)

  1. Adverse events (AEs)

    AE are assessed according to NCI CTCAE v4.03.

    Measured: one year

  2. 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: one year

  3. Duration of response (DOR)

    DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first

    Measured: one year

  4. Overall survival (OS)

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

    Measured: one year

Timeline

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

  1. First posted25 Jan 2019
  2. Study start17 Jul 2018
  3. Primary completion30 Nov 2019 (estimated)
  4. Study completion31 May 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817567
Sponsor's protocol ID
SCT200IbmESCC
Status last verified
Sep 2018
First submitted
15 Jan 2019
Last updated
25 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing recombinant anti-EGFR monoclonal antibody in people with Esophageal Squamous Cell Carcinoma, run by Sinocelltech Ltd. at 4 sites 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 10 inclusion and 17 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Foxiao Qiao, Ph D (18911165421 ext. 86-10-58628288, Foxiao_qiao@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: one 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 NCT03817567.

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 25 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in