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New treatment option for Esophageal Small Cell Carcinoma
Official title JS001 Combined With TP as First-line Treatment for Unresectable or Advanced Small Cell Esophageal Carcinoma
ClinicalTrials.gov ID: NCT05173246
What this study is testing
What is JS001?
JS001 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for esophageal small cell carcinoma.
Also referred to as recombinant humanized anti-PD-1 monoclonal antibody for injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Males and females aged 18-75 years;
- Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced / recurrent or distant metastasis
- Patients who have not received systemic anti-tumor therapy
- Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or...
- With at least 1 measurable lesion according to RECIST 1.1 criteria;
You likely can't join if
- Known allergy to study drug or excipients, or allergy to similar drugs;
- Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or...
- Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment.
- Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.
- Major surgery was performed or not completely recovered from the previous surgery within 4 weeks before enrollment (the definition of major surgery...
- The toxicity of previous anti-tumor therapy has not recovered to CTCAE [version 4.03] 0-1, except for the following cases: a) lipsotrichia；b)...
See the full eligibility criteria
- Males and females aged 18-75 years;
- Histologically or cytologically confirmed esophageal small cell carcinoma with unresectable locally advanced / recurrent or distant metastasis
- Patients who have not received systemic anti-tumor therapy
- Patients with recurrence or metastasis more than 6 months after the end of adjuvant or neoadjuvant chemotherapy accompanied by radical surgery or radical chemoradiotherapy;
- With at least 1 measurable lesion according to RECIST 1.1 criteria;
- ECOG score 0-1;
- Expected survival ≥3 months;
- Good organ function (without blood transfusion, use of hematopoietic stimulating factors, or transfusion of albumin or blood products within 7 days prior to examination): 1) Platelet (PLT) count ≥75,000 /mm3; 2)...
- Females of child bearing age must have anegative pregnancy test, and have to take contraception measures and for 3 months after the last dose
- Able to understand and willing to sign written informed consent form.
- Patients who agree to provide previously stored tumor tissue samples or perform biopsy to collect tumor tissue for gene testing.
- Known allergy to study drug or excipients, or allergy to similar drugs;
- Received anti-tumor cytotoxic drug therapy, biological drug therapy (such as monoclonal antibody), immunotherapy (such as interleukin-2 or interferon) or other research drug therapy within 4 weeks before enrollment.
- Received tyrosine kinase inhibitor treatment within 2 weeks before enrollment.
- Patients received radiotherapy within 4 weeks or radiopharmaceuticals within 8 weeks, except for local palliative radiotherapy for bone metastases.
- Major surgery was performed or not completely recovered from the previous surgery within 4 weeks before enrollment (the definition of major surgery refers to the level 3 and level 4 surgery specified in the...
- The toxicity of previous anti-tumor therapy has not recovered to CTCAE [version 4.03] 0-1, except for the following cases: a) lipsotrichia；b) Pigmentation;c) Peripheral neurotoxicity has recovered to \< CTCAE 2;d) The...
- people with clinically symptomatic CNS metastases and/or cancerous meningitis. The people who have received brain or meningeal metastasis treatment in the past, if the clinical stability has been maintained for at least...
- Have or are currently suffering from other malignancies (except for non melanoma basal cell carcinoma of the skin, breast / cervical carcinoma in situ, and other malignancies that have been effectively controlled...
- people have any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism...
- Previous use of 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 costimulation or checkpoint pathway).
- people with active pulmonary tuberculosis (TB) are receiving antituberculosis treatment or received antituberculosis treatment within one year before screening.
- Patients with complications requiring long-term use of immunosuppressive drugs or systemic or local use of corticosteroids with immunosuppressive effect (dose \> 10mg / day of prednisone or other therapeutic hormones).
- Received any anti infection vaccine (such as influenza vaccine, varicella vaccine, etc.) within 4 weeks before enrollment.
- Pregnant or lactating women.
- HIV positive.
- HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 CPS / ml).
- HCV antibody positive.
- Researchers believe that it can affect the compliance of the protocol, or affect the subject to sign the informed consent(ICF), or any other disease or condition of clinical significance that is not suitable to...
- There are clinical symptoms or diseases that can not be well controlled, such as: (1) heart failure of NYHA grade 2 or above (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.