Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adebrelimab plus CRT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adebrelimab plus chemoradiation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 2-4 weeks after neoadjuvant therapy |
| the rate of major pathologic response to neoadjuvant therapy | From enrollment to 1 month after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of surgery | 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 | From enrollment to 1 month after surgery |
Not provided
Inclusion Criteria:
1) Blood routine test: (No blood transfusion or use of G-CSF and other cytokine drugs for correction within 2 weeks before screening);
a) 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.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning XU | Contact | 8618817551990 | mouse0326@163.com | |
| TENG MAO | Contact | hippomao@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| TENG MAO | Shanghai Chest Hospital | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013945 | Thymoma |
| ID | Term |
|---|---|
| D018193 | Neoplasms, Complex and Mixed |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D013953 | Thymus Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| adverse event | From date of enrollment until 3 months after the end of treatment |
| PFS | 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 | From date of enrollment until the date of death from any cause, whichever came first, assessed up to 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |