Thymic CarcinomaPhase 2NCT07479628
Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma
A Phase 2 study testing adebrelimab plus chemoradiation in people with Thymic Carcinoma, run by Shanghai Chest Hospital.
Trial summary
The goal of this clinical trial (Phase II) is to evaluate the efficacy and safety of neoadjuvant Adebrelimab combined with chemoradiation in patients with locally advanced thymic carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thymic Carcinoma
- What is being tested?
- adebrelimab plus chemoradiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Mar 2030
- 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 and ≤ 75 years old at the time of signing the informed consent form, both male and female are eligible.
- Histologically confirmed thymic carcinoma.
- Potentially resectable locally advanced (T3/4NxM0). No previous treatment for thymic carcinoma, including but not limited to surgery, local radiotherapy, chemotherapy, immunotherapy, targeted drug therapy, and other investigational drug therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG PS score: 0-1.
- Expected survival ≥ 3 months.
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- Important organ functions must meet the following standards:
- 1) Blood routine test: (No blood transfusion or use of G-CSF and other cytokine drugs for correction within 2 weeks before screening);
- Hemoglobin (HB) ≥ 90 g/L;
- Absolute neutrophil count (ANC) ≥ 1.5×109/L;
- Platelet count (PLT) ≥ 90×109/L;
- White blood cell count (WBC) ≥ 3.0×109/L and < 15×109/L; 2) Other tests: (No human albumin injection within 14 days before screening);
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3×ULN; b) Total bilirubin (TBIL) ≤ 1.5×ULN; c) Albumin (ALB) ≥ 30 g/L; d) Creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance rate (CrCL) ≥ 50 mL/min (Cockcroft-Gault formula); e) Thyroid stimulating hormone (TSH) ≤ 1×ULN (If TSH is abnormal, FT3/T3 and FT4/T4 levels should also be examined. If FT3/T3 and FT4/T4 are normal, the patient can be enrolled); f) Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN (No anticoagulant therapy); g) Left ventricular ejection fraction (LVEF) ≥ 50%. 8. Non-surgically sterilized or female patients of childbearing age must have a negative serum pregnancy test within 3 days before the first dose of the study drug and must not be lactating. Female patients of childbearing age or male patients whose partners are of childbearing age must agree to use highly effective contraceptive methods during the study and for 6 months after the last administration of the study drug.
- 9. Patients must voluntarily join this clinical study, sign the informed consent form, have good compliance, and be able to cooperate with follow-up.
Who cannot join
- Patients with pathologies of thymoma or thymic neuroendocrine tumor.
- Patients with other malignant tumors within the past 3 years or concurrently, except for those with cured skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.
- Patients with interstitial pneumonia/interstitial lung disease (excluding those with only imaging changes), those requiring systemic glucocorticoid treatment for pneumonia (such as radiation-induced pneumonia, etc.), those with active pneumonia or severe lung function impairment confirmed by pulmonary function tests.
- Patients with any active or known autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Patients with type 1 diabetes on stable insulin therapy, hypothyroidism requiring only hormone replacement therapy, and skin diseases (such as eczema, vitiligo or psoriasis) that do not require systemic treatment and have not had acute exacerbation within 1 year before screening are allowed to be enrolled. Patients with asthma requiring medical intervention with bronchodilators cannot be included.
- Patients with active pulmonary tuberculosis. Those who have received adequate treatment and have stopped anti-tuberculosis treatment for at least 3 months before treatment can be enrolled.
- Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) New York Heart Association (NYHA) class 2 or higher heart failure (2) Unstable angina pectoris (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.
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- Patients who have experienced severe infections within 1 month before the start of treatment, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; patients with any active infections, or those with unexplained fever > 38.5°C during the screening period or before the first dose.
- Patients with a known positive history of human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS). Patients with active viral hepatitis (for hepatitis B: positive HBsAg and HBV DNA test value exceeds 500 IU; for hepatitis C: positive HCV antibody and HCV virus titer test value exceeds the upper limit of normal).
- Patients with known allergic reactions to adebiralimab or other PD-(L)1 monoclonal antibodies, or with a history of severe allergies to paclitaxel and platinum-based drugs or their prophylactic medications.
- Patients who have undergone major surgical procedures, systemic chemotherapy, immunotherapy, or other clinical trial drugs within 4 weeks before treatment; those who have received palliative radiotherapy within 2 weeks before treatment; those who have taken oral molecular targeted drugs and have stopped for less than 5 half-lives before treatment; or those who have used antibiotics within 1 week before treatment; and those who have not recovered from the toxicity and/or complications of previous interventions to NCI-CTCAE ≤ grade 1 (except for alopecia and fatigue, and the indicators mentioned in the inclusion criteria).
- According to the researcher's judgment, participants with other factors that may affect the research results or lead to the premature termination of this study, such as alcoholism, drug abuse, substance misuse, other serious diseases (including mental disorders) requiring combined treatment, severe laboratory test abnormalities, or those with family or social factors that may affect medication safety, will be excluded.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
TENG MAO contact
About this study
Official title: A Single-Arm, Prospective, Phase II Trial of Adebrelimab Plus Albumin-Bound Paclitaxel, Cisplatin, and Concurrent Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Carcinoma
The goal of this clinical trial (Phase II) is to evaluate the efficacy and safety of neoadjuvant Adebrelimab combined with chemoradiation in patients with locally advanced thymic carcinoma. The main questions it aims to answer are:
- Is neoadjuvant therapy with Adebrelimab plus chemoradiation effective?
- Is this combination treatment safe and tolerable in this patient population?
Read more
Participants will:
- Receive 2-4 cycles of neoadjuvant Adebrelimab combined with a platinum-based chemotherapy regimen (such as carboplatin plus paclitaxel) and concurrent radiotherapy prior to surgery.
- Undergo re-staging imaging to assess tumor response and determine surgical candidacy.
- Undergo surgical resection if the tumor is resectable after neoadjuvant treatment.
- Receive adjuvant Adebrelimab therapy for up to one year following surgery.
- Undergo regular follow-up visits for safety monitoring and survival assessment.
- Conditions
- Thymic Carcinoma
- Being tested
- adebrelimab plus chemoradiation
- Keywords
- thymic carcinoma, locally advanced, neoadjuvant, adebrelimab, chemoradiotherapy
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adebrelimab plus chemoradiationOther
All patients will receive 2 cycles of adebrelimab (1200mg, D1, Q1W) in combination with albumin-bound paclitaxel (70mg/m2, D1/D8/D15/D22)plus cisplatin (25mg/m2, D1/D8/D15/D22), and concurrent radiotherapy (40Gy) before surgery. If tumors are resectable after neoadjuvant therapy, surgery will be scheduled. After surgery, patients will receive adjuvant chemotherapy (2 cycles), radiotherapy (20Gy) (except for PCR disease), and adebrelimab for up to 1 year. If tumors are still unresectable after neoadjuvant therapy, patients will receive another 2 cylces of chemotherapy, radiotherapy (20Gy), and adebrelimab for up to 1 year.
| Study group | Role | What they receive |
|---|---|---|
| adebrelimab plus CRT | Experimental | Not described Receives: Other: adebrelimab plus chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the objective response rate to neoadjuvant therapy
The rate of patients with complete reseponse and partial response.
Complete response - Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm.
Partial response - Applies only to patients with at least 1 measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all targets measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
Measured: From enrollment to 2-4 weeks after neoadjuvant therapy
the rate of major pathologic response to neoadjuvant therapy
Measured: From enrollment to 1 month after surgery
Secondary outcomes (5)
the rate of surgery
Measured: From date of enrollment until the date of surgery, around 4-6 weeks after finishing neoadjuvant treatment
the rate of complete pathological response to neoadjuvant therapy
Measured: From enrollment to 1 month after surgery
adverse event
Measured: From date of enrollment until 3 months after the end of treatment
PFS
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
OS
Measured: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thymic CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teng Mao, Shanghai Chest Hospital
- Investigators
- TENG MAO, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479628
- Sponsor's protocol ID
- IS26017
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Prospective, Phase II Trial of Adebrelimab Plus Albumin-Bound Paclitaxel, Cisplatin, and Concurrent Radiotherapy for Neoadjuvant Treatment of Locally Advanced Thymic Carcinoma
- ClinicalTrials.gov ID
- NCT07479628
- Acronym / sponsor ID
- IS26017
- Conditions
- Thymic Carcinoma
- Keywords
- thymic carcinoma, locally advanced, neoadjuvant, adebrelimab, chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial (Phase II) is to evaluate the efficacy and safety of neoadjuvant Adebrelimab combined with chemoradiation in patients with locally advanced thymic carcinoma. The main questions it aims to answer are:
- Is neoadjuvant therapy with Adebrelimab plus chemoradiation effective?
- Is this combination treatment safe and tolerable in this patient population?
Participants will:
- Receive 2-4 cycles of neoadjuvant Adebrelimab combined with a platinum-based chemotherapy regimen (such as carboplatin plus paclitaxel) and concurrent radiotherapy prior to surgery.
- Undergo re-staging imaging to assess tumor response and determine surgical candidacy.
- Undergo surgical resection if the tumor is resectable after neoadjuvant treatment.
- Receive adjuvant Adebrelimab therapy for up to one year following surgery.
- Undergo regular follow-up visits for safety monitoring and survival assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adebrelimab plus CRT | Experimental | Other: adebrelimab plus chemoradiation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥ 18 and ≤ 75 years old at the time of signing the informed consent form, both male and female are eligible.
- Histologically confirmed thymic carcinoma.
- Potentially resectable locally advanced (T3/4NxM0). No previous treatment for thymic carcinoma, including but not limited to surgery, local radiotherapy, chemotherapy, immunotherapy, targeted drug therapy, and other investigational drug therapy.
- At least one measurable lesion according to RECIST 1.1 criteria.
- ECOG PS score: 0-1.
Key exclusion criteria (11 listed)
- Patients with pathologies of thymoma or thymic neuroendocrine tumor.
- Patients with other malignant tumors within the past 3 years or concurrently, except for those with cured skin basal cell carcinoma, superficial bladder cancer, skin squamous cell carcinoma, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.
- Patients with interstitial pneumonia/interstitial lung disease (excluding those with only imaging changes), those requiring systemic glucocorticoid treatment for pneumonia (such as radiation-induced pneumonia, etc.), those with active pneumonia or severe lung function impairment confirmed by pulmonary function tests.
- Patients with any active or known autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.). Patients with type 1 diabetes on stable insulin therapy, hypothyroidism requiring only hormone replacement therapy, and skin diseases (such as eczema, vitiligo or psoriasis) that do not require systemic treatment and have not had acute exacerbation within 1 year before screening are allowed to be enrolled. Patients with asthma requiring medical intervention with bronchodilators cannot be included.
- Patients with active pulmonary tuberculosis. Those who have received adequate treatment and have stopped anti-tuberculosis treatment for at least 3 months before treatment can be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adebrelimab plus chemoradiationAll patients will receive 2 cycles of adebrelimab (1200mg, D1, Q1W) in combination with albumin-bound paclitaxel (70mg/m2, D1/D8/D15/D22)plus cisplatin (25mg/m2, D1/D8/D15/D22), and concurrent radiotherapy (40Gy) before surgery. If tumors are resectable after neoadjuvant therapy, surgery will be scheduled. After surgery, patients will receive adjuvant chemotherapy (2 cycles), radiotherapy (20Gy) (except for PCR disease), and adebrelimab for up to 1 year. If tumors are still unresectable after neoadjuvant therapy, patients will receive another 2 cylces of chemotherapy, radiotherapy (20Gy), and adebrelimab for up to 1 year. | Other | adebrelimab plus CRT |
Primary outcome
the objective response rate to neoadjuvant therapy
Time frame: From enrollment to 2-4 weeks after neoadjuvant therapy
The rate of patients with complete reseponse and partial response. Complete response - Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below). No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm. Partial response - Applies only to patients with at least 1 measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all targets measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.
the rate of major pathologic response to neoadjuvant therapy
Time frame: From enrollment to 1 month after surgery
5 secondary outcomes
the rate of surgery
Time frame: From date of enrollment until the date of surgery, around 4-6 weeks after finishing neoadjuvant treatment
the rate of complete pathological response to neoadjuvant therapy
Time frame: From enrollment to 1 month after surgery
adverse event
Time frame: From date of enrollment until 3 months after the end of treatment
PFS
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
OS
Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
TENG MAO contact
TENG MAO principal investigator
Shanghai Chest Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adebrelimab plus chemoradiation in people with Thymic Carcinoma, run by Shanghai Chest Hospital.
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 14 inclusion and 11 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Ning XU (8618817551990, mouse0326@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the objective response rate to neoadjuvant therapy (time frame: From enrollment to 2-4 weeks after neoadjuvant therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.