RecruitingPhase 2NCT06838910

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

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

20 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Thymoma Thymic Carcinoma

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two drugs — tislelizumab (an immunotherapy that helps the immune system fight cancer) and anlotinib (a drug that cuts off blood supply to tumors) — works as a second-line treatment for thymoma or thymic carcinoma, which are rare cancers of the thymus gland in the chest. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with thymoma or thymic carcinoma confirmed by a lab test - Your cancer has continued to grow or came back after at least one prior chemotherapy treatment - Your general health score (ECOG) is 0 or 1 (fully active or restricted in strenuous activity only) - You have adequate blood counts, liver, and kidney function **You may NOT be eligible if...** - You have active autoimmune diseases - You have untreated brain metastases (cancer spread to the brain) - You have received certain immunotherapy drugs previously - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExperimental: tislelizumab+anlotinib

All 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.