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This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.
Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab in combination with chemotherapy and apatinib mesylate | Experimental | Adebrelimab 1200mg q3w for 4 cycles, Apatinib mesylate 250mg qod q3w 3 times/week concurrent with adebrelimab for 3 cycles, platinum-based chemotherapy (etoposide, 100mg/m2, q3w; Carboplatin, AUC=5, q3w), 4 cycles, and operation was performed within 4-8 weeks after treatment (Apatinib mesylate was discontinued for 4 weeks). According to the results of MDT discussion, adebrelimab, 1200mg q3w, and apatinib 250mg qod q3w 3 times/week were used 4 weeks after surgery, which with or without radiotherapy. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W). |
|
| Measure | Description | Time Frame |
|---|---|---|
| EFS of 2 years | The proportion of patients who did not experience any of the following events from the start of treatment to 2 years: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| MPR | MPR (Major Pathological response,) was defined as residual tumor cells ≤10% in pathological examination of postoperative specimens. | Up to 2 years |
| EFS | EFS (Event-Free Survival) refers to the time from the beginning of randomization to the first occurrence of any of the following events: disease progression without surgical treatment, local or distant recurrence, death from any cause, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Jin, MD&PhD | Contact | 86+18806529092 | jinying@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Da Chen, MD&PhD | Medical Ethics Committee Of Zhejiang Cancer Hospital | Study Chair |
| Zhengfu He, MD&PhD | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Apatinib Mesylate | Drug | This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day. |
|
| Etoposide | Drug | This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W). |
|
| Carboplatin | Drug | This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W). |
|
| Up to 2 years |
| OS | OS (Overall Survival), the time from the date of randomization until the death of the participant or the last follow-up. | Up to 2 years |
| ORR | ORR (Objective Response Rate) refers to the proportion of patients whose tumor shrinkage reaches a certain level and remains for a certain period of time, including complete response (CR) and partial response (PR) cases. | Up to 2 years |
| Treatment-Emergent Adverse Events [Safety and Tolerability] | Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0. | Up to 2 years |
| pCR | pCR, Pathological Complete Response, defined as the complete absence of all tumor cells in the primary site and lymph nodes. | Up to 2 years |
| Zhengliang Tu, MD&PhD |
| Zhejiang University |
| Principal Investigator |
| Junqiang Fan, MD&PhD | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| ID | Term |
|---|---|
| C553458 | apatinib |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
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