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Small Cell Carcinoma of EsophagusPhase 2NCT03811379

Toripalimab as Monotherapy for Patients With Small Cell Carcinoma of Esophagus Who Failed Chemotherapy

A Phase 2 study testing Toripalimab in people with Small Cell Carcinoma of Esophagus and Advanced Cancer, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the anti-tumor activity, safety and tolerance of toripalimab as monotherapy for patients with small cell esophageal cancer (SCCE), and to explore the potential biomarkers for this treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Toripalimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteChina
Study dates
21 Nov 2018to 30 Dec 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

  • Full understanding of the study and voluntary signing of informed consent
  • Histologically and/or cytologically confirmed advanced and/or metastatic small cell carcinoma of the esophagus who failed previous first-line or more lines of chemotherapy or the disease recurs within six months after the adjuvant or neoadjuvant therapy
  • At least one measurable lesion (according to RECIST 1.1) Note: Lesions previously treated with radiotherapy should not be considered as target lesions unless there is a definite progression after radiotherapy.
  • Agree to provide previously stored specimens of tumor tissue or to perform biopsy to collect tumor tissue for PD-L1 IHC detection.
  • The age ranges from 18 to 75 years with no gender limitation.
  • ECOG: 0-1
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  • Expected survival ≧ 3 months
  • Laboratory tests within 7 days before admission must meet the following criteria: A. Neutrophils≧1.5 *109/L; B. Platelet ≧ 75 *109/L; C. Hemoglobin≧90g/L (no infusion of concentrated red blood cells within 2 weeks); D. Serum creatinine≦1.5 * ULN, or creatinine clearance rate > 50 mL/min; E. Serum total bilirubin ≦ 1.5 *ULN (Gilbert syndrome subjects allowed total bilirubin ≦ 3 *ULN); F. AST and ALT ≦ 2.5 *ULN, while ALT and AST were less than 5 *ULN in subjects with liver metastasis.
  • Within 21 days before admission, women of childbearing age must confirm that the serum pregnancy test is negative and agree to use effective contraceptive measures during the study period and within 28 days after the last administration. Female reproductive age in this program is defined as sexually mature women: 1) without hysterectomy or bilateral ovariectomy, 2) natural menopause without continuous 24 months (menopause after cancer treatment does not exclude fertility) (Menstruation occurs at any time during the previous 24 consecutive months).

Who cannot join

  • known to be allergic to citric acid monohydrate, sodium citrate dihydrate, mannitol and polysorbide (components of the test drug).
  • Within the first four weeks of admission, patients received anti-tumor cytotoxic drugs, biological drugs (such as monoclonal antibodies), immunotherapy (such as interleukin-2 or interferon), or other research drugs.
  • Tyrosine kinase inhibitors were administered within 2 weeks before admission.
  • Radiotherapy or radiopharmacotherapy were given within 4 weeks or 8 weeks before admission, except local palliative radiotherapy for bone metastases.
  • Major surgical operations were performed or not fully recovered from previous operations within the first four weeks of enrollment (the definition of major surgical operations refers to the 3-and 4-level operations stipulated in the Regulations on the Clinical Application of Medical Technologies, which were implemented on 1 May 2009).
  • The toxicity of previous antineoplastic therapies has not been restored to CTCAE 0-1, except for the following cases:
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  • A alopecia; B pigmentation; C Peripheral neurotoxicity has been restored to < CTCAE level 2. D The long-term toxicity caused by radiotherapy can not be restored by the judgement of the researchers.
  • Subjects with clinical symptoms of central nervous system metastasis (e.g. brain edema, requiring hormone intervention, or progression of brain metastasis) and/or cancerous meningitis. Subjects who had previously received brain or meningeal metastasis therapy, such as clinical stability maintained for at least two months, and who had stopped systemic sex hormone therapy (prednisone or other therapeutic hormones at doses greater than 10 mg/day) for more than four weeks could be included.
  • Other malignant tumors (besides skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignancies that have not been treated and effectively controlled in the past five years) have been or are currently co-existing with other malignant tumors.
  • Subjects had any history of active autoimmune diseases or autoimmune diseases (including, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or childhood asthma had been completely alleviated; subjects without any intervention after adulthood could be included in the study; Asthma, which requires medical intervention with bronchodilators, cannot be included.
  • Anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) have been used in the past.
  • Subjects with active pulmonary tuberculosis (TB) are receiving anti-tuberculosis treatment or anti-tuberculosis treatment within one year before screening.
  • Complications of corticosteroids requiring long-term use of immunosuppressive drugs or systemic or local use of prednisone or other therapeutic hormones with an immunosuppressive dose of more than 10 mg/day.
  • Any anti-infective vaccines (such as influenza vaccine, varicella vaccine, etc.) were inoculated within 4 weeks before admission.
  • Pregnant or lactating women.
  • HIV positive.
  • HBsAg positive and HBV DNA copy number positive (quantitative detection ≧ 1000 cps/ml).
  • Blood screening for chronic hepatitis C is positive (HCV antibody is positive).
  • Researchers believe that it may affect program compliance, or the signing of informed consent (ICF), or any other disease or condition of clinical significance that is not suitable for this clinical trial.
  • Heart clinical symptoms or diseases that have not been well controlled, such as:
  • heart failure above NYHA Level 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias need treatment or intervention;

Trial locations and contacts

1 site in 1 country.

Feng Wang, MD, PhD contact

+8602087342635

lvzd@sysucc.org.cn

China1 site, 1 recruiting

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Rui-Hua Xu, MD, PhD, +862087342635, lvzd@sysucc.org.cn

    Rui-hua Xu, MD, PhD

    Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Trial of Toripalimab (JS001), a Recombinant Humanized Anti-PD-1 Monoclonal PD1 Antibody, as Monotherapy for Patients With Small Cell Esophageal Carcinoma Who Failed Chemotherapy

To evaluate the anti-tumor activity, safety and tolerance of toripalimab as monotherapy for patients with small cell esophageal cancer (SCCE), and to explore the potential biomarkers for this treatment.

Read the detailed description

For the first time in the world, the investigators revealed the genomic characteristics of SCCE and constructed a complete genomic profile of SCCE. The analysis of transcriptome data showed that the number of effector T cells in SCCE immune microenvironment was significantly higher than that of other cancers, and NK cells were relatively high. Macrophages in SCCE mainly showed M2-like phenotype and maintained at a relatively high level, suggesting the possibility of immunotherapy in SCCE treatment. Therefore, the purpose of this study is to clarify the efficacy of PD-1 antibody in the treatment of patients with SCCE who failed chemotherapy, so as to provide a basis for further large-scale clinical research.

Being tested
Toripalimab
Keywords
Immunotherapy

What participants receive

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

  • ToripalimabDrug

    Drug: Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity

Study groups in NCT03811379
Study groupRoleWhat they receive
ToripalimabExperimentalToripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
Receives: Drug: Toripalimab

What is being measured

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

  1. Objective Response Rates (ORR)

    the ratio of patients who are evaluated as CR or PR

    Measured: up to two year

Secondary outcomes (5)

  1. Progression free survival (PFS)

    defined as the time from the first dose of study treatment to disease progression

    Measured: up to two year

  2. Overall Survival (OS)

    defined as the period from the first dose of study treatment to loss of follow-up or death

    Measured: up to two year

  3. Duration of remission (DOR)

    Defined as the time between the first assessment of a tumor as PR or CR and the first assessment as PD or any cause of death

    Measured: up to two year

  4. Disease Control Rate (DCR)

    It is defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time, including CR, PR and SD.

    Measured: up to two year

  5. Adverse Events (AEs)

    All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.

    Measured: up to two year

Timeline

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

  1. First posted22 Jan 2019
  2. Study start21 Nov 2018
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 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
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811379
Sponsor's protocol ID
PD-1/SCCE
Status last verified
Jan 2019
First submitted
17 Jan 2019
Last updated
23 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Small Cell Carcinoma of Esophagus and Advanced Cancer, run by Sun Yat-sen University 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 21 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 23 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 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 Feng Wang, MD, PhD (+8602087342635, lvzd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rates (ORR) (time frame: up to two 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 NCT03811379.

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 23 Jan 2019.

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