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This is a single arm, multi-center, phase II trial to evaluate the efficacy, and safety of adebrelimab combined with famitinib and chemotherapy for the treatment of first-line extensive stage small cell lung cancer.
This study plans to recruit 40 patients with extensive-stage small cell lung disease who have not received treatment, observe and evaluate the effectiveness and safety of adebrelimab combined with famitinib and chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immuno-cherapy for extensive small cell lung cancer | Experimental | Adebrelimab in combination with famitinib and chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adebrelimab | Drug | adebrelimab IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month progression-free survival | Proportion of disease progression or death from randomization to 6 months of treatment. | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month progression-free survival | Proportion of disease progression or death from randomization to 12 months of treatment. | up to 12 months |
| Objective Response Rate | Determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points during the period from enrolment to termination of trial treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanbin Zhao, MD | Contact | 13904811741 | zhaoyanbin1978@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Yanbin Zhao, MD | Harbin Medical University Cancer Hosptital | Principal Investigator |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C584390 | famitinib |
| D004358 | Drug Therapy |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
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| famitinib | Drug | famitinib PO |
|
|
| chemotherapy | Drug | chemotherapy IV |
|
|
| up to 24 months |
| Disease control rate | Disease Control Rate, determined using RECIST v1.1 criteria. | up to 24 months |
| Overall Survival | Defined as the time from randomization to death from any cause. | up to 24 months |
| AEs | Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0. | up to 24 months |
| QoL | Defined as time from randomization to deterioration on each of the EORTC QLQ-C30 symptom subscales | up to 24 months |
| Progression-Free-Survival | Defined as the time from randomization to the first occurrence of disease progression with use of RECIST v1.1 or death from any cause, whichever occurs first. | up to 24 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017671 |
| Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |