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New treatment option for Thymic Carcinoma
Official title Neoadjuvant Treatment For Locally Advanced Thymic Cancer
ClinicalTrials.gov ID: NCT06019468
What this study is testing
- What it's testing
- The aims of this study are to verify the feasibility, effectiveness, and safety of the combination of enrolizumab and radiotherapy for neoadjuvant treatment for locally advanced thymic carcinoma, and to provide recommendations for the establishment of unified evaluation criteria for the neoadjuvant therapy of thymic cancer by evaluating the pathological remission status of thymic cancer specimens after neoadjuvant treatment.
- 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
- Pathologically confirmed as thymic carcinoma;
- Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to undergo surgical resection;
- On the day when the subject signs the informed consent form, they are ≥ 18 years old and\<75 years old, regardless of gender;
- The people are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- people who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or...
You likely can't join if
- Pathologically confirmed as a thymic neuroendocrine tumor;
- people who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular...
- Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other...
- Received live vaccines (including attenuated live vaccines) within 28 days prior to administration in this study;
- Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
- Previously or currently suffering from autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus...
See the full eligibility criteria
Who can join
- Pathologically confirmed as thymic carcinoma;
- Clinical staging III-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to undergo surgical resection;
- On the day when the subject signs the informed consent form, they are ≥ 18 years old and\<75 years old, regardless of gender;
- The people are able to understand the informed consent form, voluntarily participate, and sign the informed consent form;
- people who have not received any anti-thymic tumor treatment in the past, including but not limited to systemic chemotherapy, radiotherapy, or immunotherapy (only those who have received traditional Chinese medicine...
- At least 1 measurable lesion (according to the solid tumor how well it works evaluation standard RECIST V1.1);
- Physical fitness score of 0 or 1 (ECOG scoring system of the Eastern Cancer Collaborative Group in the United States);
- Female people with fertility must have a negative serum pregnancy test within 7 days before the first administration;
- Female people with fertility or male people with partners with fertility agree to use efficient contraceptive measures (with an annual failure rate of less than 1%) from 7 days before the first administration until 24...
- The main organ functions within 7 days before the first administration meet the following standards:
- Bone marrow function: hemoglobin ≥ 10.0 g/dL (no blood transfusion received within 28 days before hemoglobin test), absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L (no platelet transfusion or IL-11...
- Coagulation function: INR and PT\<1.5 × ULN, APTT ≤ 1.5 × ULN;
- Liver function: transaminases (ALT and AST) ≤ 2.5 × ULN; Total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 2.5 in people with Gilbert's syndrome or liver metastasis) × ULN);
- Renal function: serum creatinine clearance rate ≥ 60 mL/min (calculated according to Cockcroft Fault formula);
- Adequate lung function: According to the doctor's judgment, lung function can meet the requirements of thymectomy surgery.
What rules you out
- Pathologically confirmed as a thymic neuroendocrine tumor;
- people who have undergone major surgical treatment (such as abdominal or thoracic surgery; excluding diagnostic puncture or peripheral vascular pathway replacement surgery) or have not recovered from surgical treatment...
- Within 14 days before the first administration of this study, systemic corticosteroids (≥ 10 mg/day prednisone, or equivalent amounts of other corticosteroids) or immunosuppressive therapy are required for 7 consecutive...
- Received live vaccines (including attenuated live vaccines) within 28 days prior to administration in this study;
- Previously or currently suffering from interstitial pneumonia/lung disease that requires systemic hormone therapy;
- Previously or currently suffering from autoimmune diseases, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener syndrome (granulomatosis of vasculitis...
- Other malignant tumors were combined within 5 years before the first administration, excluding cured skin squamous cell carcinoma, basal cell carcinoma, non-muscle invasive bladder cancer, localized low-risk prostate...
- Have uncontrolled heart, kidney, gastrointestinal tract, infectious diseases and other complications;
- Previous history of allogeneic bone marrow or organ transplantation;;
- Previously treated with any antibody/drug (immune checkpoint) targeting T cell co-regulatory proteins, such as anti PD (L) 1, CTLA-4, 4-1BB, LAG 3, TIM 3, or anti CD127; Previously received anti-tumor vaccine treatment
- Previous history of allergic reactions to antibody-based drugs and intolerance (≥ Level 3 NCI-CTCAE V5.0); Any past history of rapid allergic reactions and uncontrollable asthma (i.e. uncontrollable asthma symptoms of 3...
- Pregnant and/or lactating women;
- Other situations that may affect the safety or compliance of drug treatment in this study, including but not limited to mental illness, uncontrolled large amounts of serous fluid accumulation, or people who require...
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 to 75 years. 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.