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This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Etoposide | Experimental | Etoposide: PO, 50 mg, d1-d14, Q3W |
|
| Etoposide+Toripalimab | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ,Q3W; |
|
| Toripalimab+Etoposide+Anlotinib | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ,Q3W; Anlotinib: 12mg, d1-d14, PO, Q3W; |
|
| Toripalimab+Etoposide+Carboplatin | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ,Q3W; Carboplatin: AUC=5, d1, ivgtt, Q3W |
|
| Etoposide+Toripalimab+Temozolomide | Experimental | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ,Q3W; Temozolomide: 75mg/m ² /d, d1-d21, PO, Q4W; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab; Etoposide | Drug | Toripalimab: 240 mg ,D1, ivgtt, Q3W; Etoposide: PO, 50 mg, d1-d14 ,Q3W; carboplatin: AUC=5,d1, ivgtt,, Q3W; temozolomide:75mg/m2/d,d1-d21,PO,Q4W; Anlotinib:12mg,d1-d14 PO,Q3W |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | According to the RECIST 1.1 standard, the proportion of patients whose tumors have shrunk to a complete response (CR) or partial response (PR) and have maintained this condition for at least 4 weeks | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
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Inclusion Criteria:
1.Age ≥18 years old, both male and female are acceptable.
2. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:
3. ECOG: 0 ~ 2;
4 . The expected lifetime 12 weeks or more;
5. Major organs function normal
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiming Wang | Contact | 4000371818 | qimingwang1006@126.com |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D005047 | Etoposide |
| D016190 | Carboplatin |
| D000077204 | Temozolomide |
| C000625192 | anlotinib |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |