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Tests treatment safety and results for Esophageal Squamous Cell Carcinoma
Official title Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT07266493
What this study is testing
What is Chemotherapy （Albumin bound paclitaxel and Carboplatin）?
Chemotherapy （Albumin bound paclitaxel and Carboplatin） is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for esophageal squamous cell carcinoma.
Also referred to as Albumin bound paclitaxel and Carboplatin.
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
- This single center, prospective, single arm clinical study aims to evaluate the clinical efficacy and safety of Envafolimab combined with albumin bound paclitaxel and carboplatin as neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma.
- 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 and older
You may be able to join if
- The people voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
- Age ≥ 18 years old (when signing the informed consent form);
- ECOG score 0-1 points;
- Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
- The clinical TNM staging is T2-4aNxM0
You likely can't join if
- The people have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial...
- The subject has previous or concurrent malignant tumors;
- Patients who have received systemic anti-tumor therapy in the past;
- Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of...
- There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric...
- It is known that the subject has a history of allergies to large molecule protein preparations or drug ingredients used;
See the full eligibility criteria
- The people voluntarily joined this study, were able to sign the informed consent form, and had good compliance;
- Age ≥ 18 years old (when signing the informed consent form);
- ECOG score 0-1 points;
- Diagnosed with operable esophageal squamous cell carcinoma through pathological diagnosis (pathological tissue/cytology) and imaging;
- The clinical TNM staging is T2-4aNxM0
- Patients assessed to require routine neoadjuvant therapy;
- Have not received immunotherapy, chemotherapy, targeted therapy, or radiotherapy in the past;
- Expected survival ≥ 12 weeks
- The people have any active autoimmune diseases or a history of autoimmune diseases (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis...
- The subject has previous or concurrent malignant tumors;
- Patients who have received systemic anti-tumor therapy in the past;
- Individuals who have undergone significant surgical treatment, open biopsy, or significant traumatic injury within 28 days prior to the start of treatment; Or there may be wounds or fractures that have not been cured...
- There is a risk of bleeding, coagulation dysfunction, or currently undergoing thrombolytic therapy; Or have experienced esophageal or gastric variceal rupture bleeding in the past 6 months;
- It is known that the subject has a history of allergies to large molecule protein preparations or drug ingredients used;
- people with any severe and/or uncontrolled illnesses
- Ascites or pleural effusion with clinical symptoms cannot be controlled with medication and require therapeutic puncture or drainage;
- The subject is known to have a history of substance abuse, alcoholism, or drug use;
- The researchers believe that participants should be excluded from this study, for example, if the researchers determine that there are other factors that may cause the study to be terminated midway
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, 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.