Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Feb 18, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with thymoma and thymic carcinoma who have not responded well to their initial chemotherapy. The trial will test a combination of two drugs, tislelizumab and anlotinib, to see if this combination is safe and effective as a second-line treatment. The researchers aim to recruit 20 participants who are between 18 and 75 years old and have experienced disease progression after their first treatment. Eligible participants must have a confirmed diagnosis of thymoma or thymic carcinoma, have measurable tumors, and be in generally good health.

If you or a loved one is considering participating, you can expect to receive the combination treatment in an open-label setting, meaning both the participants and the researchers will know what treatment is being given. Participants will need to undergo various health checks to ensure they meet the study's criteria, including tests for blood cell counts and organ function. It’s important to note that this trial is not yet recruiting, so there will be a wait before it starts. Additionally, participants will need to sign an informed consent form, which means they will be fully informed about the study before agreeing to take part.

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ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-75 years old, gender is not limited.
• • 2. Histologically or cytologically confirmed thymoma or thymic carcinoma.
• • 3. Disease progression during or after first-line chemotherapy (with or without immunotherapy).
• • 4. At least one measurable solid tumor lesion according to RECIST 1.1 criteria.
• • 5. Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point.
• 6. Vital organ function meets the following criteria:
• • 1. 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; iii. hemoglobin (Hb) ≥80g/L;
• • 2. 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;
• • 3. left ventricular ejection fraction (LVEF) ≥50%;
• • 7. Female subjects 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 subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 8 weeks after the end of the last treatment session.
• • 8. Informed consent was signed.
• Exclusion Criteria:
• • 1. Prior treatment with anlotinib or any other anti-angiogenesis drugs.
• • 2. Patients with symptomatic brain metastasis.
• • 3. Other primary malignancy in the past 5 years, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma).
• • 4. Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis.
• • 5. Severe infections within 4 weeks prior to inclusion.
• 6. Any of the following severe acute comorbidities prior to inclusion:
• • 1. Does not have uncontrolled pleural effusion/pericardial effusion/or ascites as determined by the investigator;
• • 2. Unstable angina myocardial infarction or uncontrolled congestive heart failure within 12 months;
• • 3. Uncontrollable hypertension;
• • 4. Urine routine test protein ≥++, and confirmed 24 hours urine protein\> 1.0 g;
• • 7. 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;
• • 8. 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 bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis;
• • 9. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to inclusion.
• • 10. Presence of any mental disease or drug abuse disorder that may interfere with subject's ability for being compliant with study requirements.
• • 11. Known hypersensitivity or allergy to monoclonal antibody.
• • 12. Is receiving systemic steroid therapy \< 2 weeks prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.
• • 13. Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other immunosuppressive therapy that was continued within 2 weeks prior to the first dose.
• • 14. Participation in another clinical trial within 28 days.
• • 15. Any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results.