Tislelizumab plus anlotinib as a second-line treatment for 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

This trial will test whether combining tislelizumab with anlotinib is safe and can control thymoma or thymic carcinoma in people whose cancer progressed after first-line chemotherapy (with or without immunotherapy).

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: anlotinib, chemotherapy, immunotherapy, tislelizumab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06838910 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm, single-center Phase II trial in China that plans to enroll about 20 patients with thymoma or thymic carcinoma who progressed after first-line chemotherapy (with or without immunotherapy). Eligible participants are adults aged 18–75 with histologically confirmed disease, at least one measurable lesion per RECIST 1.1, ECOG 0–1, estimated survival ≥3 months, and adequate hematologic, hepatic and cardiac function. Participants will receive a combination of the PD‑1 antibody tislelizumab and the oral anti‑angiogenic tyrosine kinase inhibitor anlotinib, with safety and anti-tumor activity monitored over time. The trial's main goals are to record adverse events and measure tumor response and disease control using standard radiologic criteria.

Who should consider this trial

Good fit: Adults 18–75 with confirmed thymoma or thymic carcinoma who progressed after first-line chemotherapy (with or without immunotherapy), have at least one measurable lesion, ECOG performance status 0–1, and adequate organ and cardiac function are the intended participants.

Not a fit: Patients with poor performance status, expected survival under three months, inadequate blood, liver or cardiac function, or who cannot attend the Nanjing study center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the combination could provide a new second-line option that shrinks tumors or delays disease progression for patients with thymoma or thymic carcinoma.

How similar studies have performed: Combinations of PD‑1 inhibitors and anti‑angiogenic agents have shown promising activity in several cancers, but evidence specifically in thymoma and thymic carcinoma remains limited.

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.

Where this trial is running

Nanjing, Jiangsu

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wen Gao

Conditions Thymic Carcinoma; Thymoma