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The purpose of this study is to assess time window, efficacy and safety of patients who receive anti-PD-1 antibody multimodal combination as first-line treatment of advanced solid tumor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab/sintilimab+ Standard chemotherapy | Drug | Camrelizumab/sintilimab:200mg,iv,30min,d4,q3w,24 months Standard chemotherapy:Researcher chooses standard treatment by recommended guidelines,d 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 24 months |
| DCR | Baseline to measured progressive disease |
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Inclusion Criteria:
1) For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥90×109/L; 2) For results of blood biochemical test ALB≥30g/L ALT and AST<2.5×ULN, but<5×ULN if the transferanse elevation is due to liver metastases; TBIL≤1.5×ULN; Serum creatinine ≤1.5×ULN; 8. Left ventricular ejection fraction (LVEF) ≥50%; 9. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 10. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Shi, Ph.D | Contact | 13831110729 | shijian6668@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoen Shan, Ph.D | Hebei Medical University Fourth Hospital | Principal Investigator |
| Jian Shi, Ph.D | Hebei Medical University Fourth Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | China |
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| Camrelizumab/sintilimab+ apatinib(Intolerance to chemotherapy / refuse chemotherapy) | Drug | Camrelizumab/sintilimab:200mg,iv,30min,d4,q3w,24 months Apatinib:250mg,d1,qd,po |
|
| Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy | Drug | Camrelizumab/sintilimab:200mg,iv,30min,d7,q3w,24 months Apatinib:250mg,d1,qd,po Standard chemotherapy:Researcher chooses standard treatment by recommended guidelines,d 1-3 |
|
| tumor assessment every 6 weeks since the treatment began,up to 24 months |
| OS | Overall survival | the first day of treatment to death or last survival confirm date,up to 24 months |
| Adverse events | Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit. | up to 24 weeks |
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
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