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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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).

Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis.

Trial design

Treatments tested in this trial

  • Experimental: tislelizumab+anlotinib

Treatment groups

20 Participants
are divided into 1 treatment group