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

NCT06838910 | Recruiting Phase 2

• 1 other identifier: 2024-SR-694
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thymic Carcinoma; Thymoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Two years of observation after enrollment

Secondary Outcomes (3)

• Overall Survival (OS)

  Two years of observation after enrollment

• Progression free survival (PFS)

  Two year of observation after enrollment

• Duration of response (DOR)

  24 months

Study Arms (1)

Tislelizumab + Anlotinib

EXPERIMENTAL

Drug: Experimental: tislelizumab+anlotinib

Interventions

Experimental: tislelizumab+anlotinib DRUG

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.

Tislelizumab + Anlotinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point.
• Vital organ function meets the following criteria:
• 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;
• 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;
• left ventricular ejection fraction (LVEF) ≥50%;
• 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.
• Informed consent was signed.

You may not qualify if:

• 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.
• Does not have uncontrolled pleural effusion/pericardial effusion/or ascites as determined by the investigator;
• Unstable angina myocardial infarction or uncontrolled congestive heart failure within 12 months;
• Uncontrollable hypertension;
• Urine routine test protein ≥++, and confirmed 24 hours urine protein\> 1.0 g;
• 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;
• 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;
• Presence of any mental disease or drug abuse disorder that may interfere with subject's ability for being compliant with study requirements.
• Known hypersensitivity or allergy to monoclonal antibody.
• Is receiving systemic steroid therapy \< 2 weeks prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication.
• Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other immunosuppressive therapy that was continued within 2 weeks prior to the first dose.
• Participation in another clinical trial within 28 days.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Thymoma

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Wen Gao

CONTACT

+8613951619963; Yoghurt831030@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 21, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)