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.
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.
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.
Single group
Experimental: tislelizumab+anlotinib
DrugAll patients will receive tislelizumab 200mg on Day1 every 3-week plus anlotinib 12mg or 10mg or 8mg on Day 1-14 every 3-week (Q3W) until disease progression.
Objective Response Rate (ORR)
Objective Response Rate (ORR) refers to the proportion of patients whose cancer shrinks (partial response) or disappears (complete response) after treatment.
Overall Survival (OS)
The time from enrollment to death due to any reason.
Progression free survival (PFS)
The time from the beginning of randomization to the progression of tumor development or death for any reason.
Duration of response (DOR)
DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death.
Click on the lead sponsor to view all of their trials.
