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New treatment option for Thymic Carcinoma
Official title Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma
ClinicalTrials.gov ID: NCT06838910
What this study is testing
What is Experimental: tislelizumab+anlotinib?
Experimental: tislelizumab+anlotinib is an investigational medicine, being studied as a potential treatment for thymic carcinoma.
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
- It is an open-lable, single-arm, single-center, phase II clinical trial conducted in China, and plan to recruiting 20 patients who were progressed after first line chemotherapy or chemotherapy combined with immunotherapy. The purpose of this study is to evaluate the safety and efficacy of tislelizumab combined with anlotinib as second-line in thymoma and thymic 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 to 75
You may be able to join if
- Age 18-75 years old, gender is not limited.
- Histologically or cytologically confirmed thymoma or thymic carcinoma.
- Disease progression during or after first-line chemotherapy (with or without immunotherapy).
- At least one measurable solid tumor lesion according to RECIST 1.1 criteria.
- Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point.
You likely can't join if
- Prior treatment with anlotinib or any other anti-angiogenesis drugs.
- Patients with symptomatic brain metastasis.
- Other primary malignancy in the past 5 years, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma).
- people with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis.
- Severe infections within 4 weeks prior to inclusion.
- Any of the following severe acute comorbidities prior to inclusion:
See the full eligibility criteria
- Age 18-75 years old, gender is not limited.
- Histologically or cytologically confirmed thymoma or thymic carcinoma.
- Disease progression during or after first-line chemotherapy (with or without immunotherapy).
- At least one measurable solid tumor lesion according to RECIST 1.1 criteria.
- Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point.
- Vital organ function meets the following criteria:
- Hematological examination (no use of any blood components and cell growth factors within 14 days prior to initiation of study treatment): i. neutrophil count (ANC) ≥ 1.5×109/L; ii. platelet count (PLT) ≥100 × 109/L...
- total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5× ULN, serum albumin (ALB) ≥28g/L;
- left ventricular ejection fraction (LVEF) ≥50%;
- Female people of childbearing potential must have a serum pregnancy test within 7 days prior to the first dose with a negative result; and must be non-lactating; Female people of childbearing potential and male people...
- Informed consent was signed.
- Prior treatment with anlotinib or any other anti-angiogenesis drugs.
- Patients with symptomatic brain metastasis.
- Other primary malignancy in the past 5 years, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma).
- people with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis.
- Severe infections within 4 weeks prior to inclusion.
- Any of the following severe acute comorbidities prior to inclusion:
- Does not have uncontrolled pleural effusion/pericardial effusion/or ascites as determined by the investigator;
- Unstable angina myocardial infarction or uncontrolled congestive heart failure within 12 months;
- Uncontrollable hypertension;
- Urine routine test protein ≥++, and confirmed 24 hours urine protein\> 1.0 g;
- Imaging shows that the tumor has invaded a vital vessel perimeter or who, in the opinion of the investigator, have a high likelihood of fatal hemorrhage due to tumor invasion of a vital vessel during the follow-up study;
- Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal...
- Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to inclusion.
- Presence of any mental disease or drug abuse disorder that may interfere with subject's ability for being compliant with study requirements.
- Known hypersensitivity or allergy to monoclonal antibody.
- Is receiving systemic steroid therapy \< 2 weeks prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.
- Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other immunosuppressive therapy that was continued within 2 weeks prior to the first dose.
- Participation in another clinical trial within 28 days.
- Any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, 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 Nanjing, Jiangsu, 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.