New drug combo aims to fight rare thymus cancers after first treatment fails
NCT ID NCT06838910
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.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, Jiangsu, 210000, China
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