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Not yet recruitingNCT07479628Updated Mar 18, 2026

Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma

A Phase 2 interventional study of adebrelimab plus chemoradiation in Thymic Carcinoma, sponsored by Shanghai Chest Hospital. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Shanghai Chest Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
31
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Thymic Carcinoma

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Keywords

  • thymic carcinoma
  • locally advanced
  • neoadjuvant
  • adebrelimab
  • chemoradiotherapy
03

In context

Thymoma

133 studies on the registry are indexed under Thymoma; 37 are open to participants now.

This study's planned enrollment of 31 is below the median of 44 across 108 interventional studies indexed under Thymoma.

Browse Thymoma studies →

Lead sponsor

Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 and ≤ 75 years old at the time of signing the form, both male and female are eligible.
  2. confirmed thymic carcinoma.
  3. 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 drug therapy.
  4. At least one according to 1.1 criteria.
  5. PS score: 0-1.
  6. Expected survival ≥ 3 months.
  7. 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);

  1. (HB) ≥ 90 g/L;
  2. (ANC) ≥ 1.5×109/L;
  3. count (PLT) ≥ 90×109/L;
  4. 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);

a) (ALT) and aspartate aminotransferase (AST) ≤ 3×; b) Total (TBIL) ≤ 1.5×ULN; c) Albumin (ALB) ≥ 30 g/L; d) Creatinine (Cr) ≤ 1.5×ULN, or 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) (APTT) ≤ 1.5×ULN, international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5×ULN (No anticoagulant therapy); g) (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 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.

Exclusion criteria

Exclusion Criteria:

  1. Patients with pathologies of thymoma or thymic neuroendocrine tumor.
  2. 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.
  3. Patients with interstitial pneumonia/interstitial lung disease (excluding those with only imaging changes), those requiring systemic treatment for pneumonia (such as radiation-induced pneumonia, etc.), those with active pneumonia or severe lung function impairment confirmed by pulmonary function tests.
  4. Patients with any active or known 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.
  5. 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.
  6. Patients with uncontrolled clinical symptoms or diseases of the heart, such as: (1) (NYHA) class 2 or higher heart failure (2) Unstable angina pectoris (3) Myocardial infarction within 1 year (4) supraventricular or ventricular arrhythmias requiring treatment or intervention.
  7. 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.
  8. Patients with a known positive history of (HIV) test or acquired immune deficiency syndrome (AIDS). Patients with active viral hepatitis (for : positive HBsAg and HBV DNA test value exceeds 500 IU; for : positive HCV antibody and HCV virus titer test value exceeds the ).
  9. 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.
  10. 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 ≤ grade 1 (except for alopecia and fatigue, and the indicators mentioned in the inclusion criteria).
  11. 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.
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (estimated)

Study arms

  • Experimental
    adebrelimab plus CRT

    Other: adebrelimab plus chemoradiation

Interventions

  • Otheradebrelimab plus chemoradiation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to 2-4 weeks after neoadjuvant therapy

  2. the rate of major pathologic response to neoadjuvant therapy

    Time frame: From enrollment to 1 month after surgery

Secondary outcomes

  1. the rate of surgery

    Time frame: From date of enrollment until the date of surgery, around 4-6 weeks after finishing neoadjuvant treatment

  2. the rate of complete pathological response to neoadjuvant therapy

    Time frame: From enrollment to 1 month after surgery

  3. adverse event

    Time frame: From date of enrollment until 3 months after the end of treatment

  4. 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

  5. OS

    Time frame: From date of enrollment until the date of death from any cause, whichever came first, assessed up to 36 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07479628
Responsible party
Teng Mao (Dr., Shanghai Chest Hospital) — Principal investigator
First posted
Mar 18, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Mar 1, 2028 (estimated)
Completion
Mar 1, 2030 (estimated)
Last update
Mar 18, 2026

Study contacts

Ning XU
Contact
mouse0326@163.com
8618817551990
TENG MAO
Contact
hippomao@hotmail.com
TENG MAO
principal investigator · Shanghai Chest Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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