New drug combo aims to fight rare thymus cancers after first treatment fails

NCT ID NCT06838910

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a combination of two drugs—tislelizumab (an immunotherapy) and anlotinib (a targeted therapy)—as a second-line treatment for people with thymoma or thymic carcinoma whose cancer has progressed after initial chemotherapy. The study will enroll 20 participants at a single center in China. The main goal is to see how many patients experience tumor shrinkage or disappearance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tislelizumab (an immunotherapy drug) combined with anlotinib (a targeted therapy drug)
What this could lead to
If successful, this combination could offer a new second-line treatment option for people with thymoma or thymic carcinoma whose cancer has progressed after initial therapy.
What could go wrong
This is a small, early-phase trial with only 20 participants, so results may not apply broadly. The combination may cause side effects or fail to shrink tumors in many patients.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 18-75 years old, gender is not limited. 2. Histologically or cytologically confirmed thymoma or thymic carcinoma. 3. Disease progression during or after first-line chemotherapy (with or without immunotherapy). 4. At least one measurable solid tumor lesion according to RECIST 1.1 criteria. 5. Estimated survival ≥ 3 months; United States Eastern Cooperative Oncology Group (ECOG) score: 0 or 1 point. 6. Vital organ function meets the following criteria: 1. 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; 2. 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; 3. left ventricular ejection fraction (LVEF) ≥50%; 7. 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. 8. Informed consent was signed. Exclusion Criteria: 1. Prior treatment with anlotinib or any other anti-angiogenesis drugs. 2. Patients with symptomatic brain metastasis. 3. Other primary malignancy in the past 5 years, with the exception of: (radical Non-melanoma skin cancer or cured cervical in-situ carcinoma). 4. Subjects with active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. 5. Severe infections within 4 weeks prior to inclusion. 6. Any of the following severe acute comorbidities prior to inclusion: 1. Does not have uncontrolled pleural effusion/pericardial effusion/or ascites as determined by the investigator; 2. Unstable angina myocardial infarction or uncontrolled congestive heart failure within 12 months; 3. Uncontrollable hypertension; 4. Urine routine test protein ≥++, and confirmed 24 hours urine protein\> 1.0 g; 7. 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; 8. 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; 9. Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to inclusion. 10. Presence of any mental disease or drug abuse disorder that may interfere with subject's ability for being compliant with study requirements. 11. Known hypersensitivity or allergy to monoclonal antibody. 12. Is receiving systemic steroid therapy \< 2 weeks prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication. 13. Diagnosis of immunodeficiency or undergoing systemic glucocorticoid therapy or any other immunosuppressive therapy that was continued within 2 weeks prior to the first dose. 14. Participation in another clinical trial within 28 days. 15. Any condition that, in the opinion of the investigator, would interfere with evaluation or interpretation of patient safety or study results.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, 210000, China

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