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Thymic CarcinomaPhase 2NCT06838910

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

A Phase 2 study testing Experimental: tislelizumab+anlotinib in people with Thymic Carcinoma and Thymoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Thymic Carcinoma, Thymoma
What is being tested?
Experimental: tislelizumab+anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
31 Mar 2025to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
  • Severe infections within 4 weeks prior to inclusion.
  • Any of the following severe acute comorbidities prior to inclusion:
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  • 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;
  • Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to inclusion.
  • 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.
  • Any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wen Gao contact

+8613951619963

Yoghurt831030@126.com

China1 site, 1 recruiting

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210000

    Wen Gao, +8613951619963, Yoghurt831030@126.com

    Recruiting

Other trials in China

About this study

Official title: Tislelizumab Combined With Anlotinib as Second-line Therapy in Thymoma and Thymic Carcinoma: An Open-label, Single-centre, Phase 2 Study

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.

Being tested
Experimental: tislelizumab+anlotinib
Medical subject headings
Thymoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: tislelizumab+anlotinibDrug

    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.

Study groups in NCT06838910
Study groupRoleWhat they receive
Tislelizumab + AnlotinibExperimentalNot described
Receives: Drug: Experimental: tislelizumab+anlotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Two years of observation after enrollment

Secondary outcomes (3)

  1. Overall Survival (OS)

    The time from enrollment to death due to any reason.

    Measured: Two years of observation after enrollment

  2. Progression free survival (PFS)

    The time from the beginning of randomization to the progression of tumor development or death for any reason.

    Measured: Two year of observation after enrollment

  3. 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2025
  2. Study start31 Mar 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06838910
Sponsor's protocol ID
2024-SR-694
Status last verified
Feb 2025
First submitted
18 Feb 2025
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Experimental: tislelizumab+anlotinib in people with Thymic Carcinoma and Thymoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wen Gao (+8613951619963, Yoghurt831030@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Two years of observation after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06838910.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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