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| Name | Class |
|---|---|
| Peking University First Hospital | OTHER |
| Peking University Third Hospital | OTHER |
| Beijing Shijitan Hospital, Capital Medical University | OTHER |
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This study is a single-arm, prospective, multi-center clinical trial. designed to evaluate patients with stage IV inability to receive or refuse chemotherapy.Efficacy and safety of first-line treatment with Camrelizumab and Endo in advanced lung squamous cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab (SHR-1210) Combined With Endostar | Experimental | Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab | Drug | Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes (the overall infusion time including the flushing time is not shorter than 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance. The combination regimen is a medication cycle every three weeks (21 days). |
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression-Free survival) | From the date Into this study (signed ICF) to tumor progression or death for any | 1 Year |
| One year survival rate | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective control rate) | The rate of CR and PR | From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months. |
| DCR (Disease control rate) | the rate of CR, PR plus SD |
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Inclusion Criteria:
Subjects >/= 18 years of age at the time of Informed Consent.
Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) have a histologically or cytologically confirmed stage IV (American Joint Committee on Cancer [AJCC] 8th edition) , and the stage IIIB/IIIC SqNSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy.
.No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
Life expectancy of at least three months.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm, the short diameter of CT scan of the lymph node lesions > 15 mm).
The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
Subject dosen't have unhealed wounds before enrollment.
Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-1210. Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barriermethods of contraception from screening through 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-1210.
Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Fang | Contact | +86-010-88196459 | bch2_mg@163.com | |
| HengWei Hu | Contact | +86-010-88196459 | bch2_mg@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Fang | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C522911 | endostar protein |
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| Chinese PLA General Hospital |
| OTHER |
| Peking Union Medical College Hospital | OTHER |
| Peking University People's Hospital | OTHER |
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| From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months. |
| DOR(Duration of response) | Cr or PR to the first assessment of PD or death from any cause | From the date Into this study (signed ICF) to tumor progression,assessed up to 36 months. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |