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Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma: An Open-label, Single-centre, Phase 2 Study

NCT06838910•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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;
+9 more criteria

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

March 31, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 30, 2026

Last Updated

December 1, 2025

Enrollment

ESTIMATED participants

Conditions

Thymic CarcinomaThymoma

Interventions

Experimental: tislelizumab+anlotinib

DRUG

Contacts

Wen Gao

CONTACT

+8613951619963 Yoghurt831030@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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