Neoadjuvant Adebrelimab Plus CRT for Locally Advanced Thymic Carcinoma
ConditionThymic Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Chest Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
adebrelimab plus chemoradiation
Other interventionAll 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.
Treatment groups
31 Participants
are divided into 1 treatment groupGroup A: adebrelimab plus CRTExperimental treatment 1 intervention
Trial outcomes
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 therapy2
the rate of major pathologic response to neoadjuvant therapy
Time frame
From enrollment to 1 month after surgerySecondary outcomes
1
the rate of surgery
Time frame
From date of enrollment until the date of surgery, around 4-6 weeks after finishing neoadjuvant treatment2
the rate of complete pathological response to neoadjuvant therapy
Time frame
From enrollment to 1 month after surgery3
adverse event
Time frame
From date of enrollment until 3 months after the end of treatment4
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 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: