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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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The regimen of paclitaxel+cisplatin+TQB2450 injection combined or not combined with anlotinib is the first-line treatment of advanced esophageal squamous cell carcinoma. Take PFS as the main evaluation index, the purpose is to evaluate its effectiveness and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group 1 | Experimental | Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib (4-6 cycles). Maintenance treatment: TQB2450 injection+Anlotinib. |
|
| Experimental group 2 | Experimental | Initial treatment: Paclitaxel + Cisplatin + TQB2450 injection (4-6 cycles). Maintenance treatment: TQB2450 injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib | Drug | TQB2450 injection: 1200 mg, i.v.gtt , d1;Anlotinib 10mg, po.qd , d1-14;Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to Anlotinib (10mg, po.qd , d1-14)+TQB2450 injection(1200 mg, i.v.gtt , d1). The regimen is repeated every 3 weeks until the disease progresses. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS, RECIST assessment) | each 42 days(Initial treatment) or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity (Up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (iPFS) | each 42 days(Initial treatment) or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity (Up to 24 months) | |
| Objective response rate (ORR) | each 42 days(Initial treatment) or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity (Up to 24 months) |
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Inclusion Criteria:
Histologically or cytologically confirmed squamous cell carcinoma of the esophagus, locally advanced, unresectable, recurrent or metastatic disease.
Those who have not received systemic treatment before, or who relapsed after (new) adjuvant therapy/radical surgery more than 6 months ; Note: Including advanced or recurrent Patients who ever received only radiotherapy on non-target lesions. The duration from the end of palliative treatment for local lesions (non-target lesions) to enrollment should > 2 weeks;
According to RECIST 1.1, at least one measurable lesion; the measurable lesions should not have received local treatment such as radiotherapy (for the lesions in the area where received local radiotherapy, it can also be regarded as a target lesion if confirmed to progress according to the recist1.1);
18 and 75 years old;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;Life expectancy of at least 3 months.
the main organ function to meet the following criteria:
(1)Blood routine tests met the following requirements:
a) haemoglobin(HB)≥90g/L ; b) absolute neutrophil count(NEUT)≥1.5×109/L ; c) platelet count(PLT)≥100×109/L;
(2) Biochemical tests met the following requirements: total bilirubin(TBIL)≤ 1.5 times the upper limit of normal (ULN) .≤5 × ULN if with liver involvement; serum creatinine ≤1.5 × the ULN or creatinine clearance≥50mL/min。
(3) Coagulation or thyroid function meet the following criteria: International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PT) or activated PTT (APTT) ≤1.5 × (ULN))."
Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 3 months after the last dose of study
The patient volunteers to participate in the study, signs a consent form, has good compliance, and obeys the follow-up, and is willing and able to follow the protocol during the study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suxia Luo, Doctor | Contact | 0371-65587697 | 2290773710@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Suxia Luo, Doctor | Henan Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AnYang Tumor Hospital | Anyang | Henan | 455000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31781673 | Background | Lu D, Ni Z, Liu X, Feng S, Dong X, Shi X, Zhai J, Mai S, Jiang J, Wang Z, Wu H, Cai K. Beyond T Cells: Understanding the Role of PD-1/PD-L1 in Tumor-Associated Macrophages. J Immunol Res. 2019 Nov 4;2019:1919082. doi: 10.1155/2019/1919082. eCollection 2019. | |
| 28361267 | Background | Ramjiawan RR, Griffioen AW, Duda DG. Anti-angiogenesis for cancer revisited: Is there a role for combinations with immunotherapy? Angiogenesis. 2017 May;20(2):185-204. doi: 10.1007/s10456-017-9552-y. Epub 2017 Mar 30. |
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|
| Paclitaxel + Cisplatin + TQB2450 injection | Drug | TQB2450 injection: 1200 mg, i.v.gtt , d1;Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to TQB2450 injection(1200 mg, i.v.gtt , d1). The regimen is repeated every 3 weeks until the disease progresses. |
|
| Disease control rate (DCR) | each 42 days(Initial treatment) or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity (Up to 24 months) |
| Duration of response (DOR) | each 42 days(Initial treatment) or 63 days ( Maintenance treatment) up to Progressive Disease or Intolerable toxicity (Up to 24 months) |
| Incidence of Treatment-related adverse Events | Through study completion, an average of 3 weeks |
| The People's Hospital Of AnYang City | Anyang | Henan | 455000 | China |
|
| First Affiliated Hospital of Henan University of Science and Technolog | Luoyang | Henan | 471000 | China |
|
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450003 | China |
|
| Henan Cancer Hospital | Zhengzhou | Henan | 450008 | China |
|
| Background | [1]He Jie, Shao Kang. The epidemiology, diagnosis and treatment of esophageal cancer in China and future strategies[J]. Chinese Journal of Cancer, 2011, 21(07): 501-504. |
| 26895815 | Result | Gandini S, Massi D, Mandala M. PD-L1 expression in cancer patients receiving anti PD-1/PD-L1 antibodies: A systematic review and meta-analysis. Crit Rev Oncol Hematol. 2016 Apr;100:88-98. doi: 10.1016/j.critrevonc.2016.02.001. Epub 2016 Feb 10. |
| 29545714 | Result | Chen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01. |
| 30207593 | Result | Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. |
| Result | Guidelines Working Committee of Chinese Society of Clinical Oncology. Guidelines for Diagnosis and Treatment of Esophageal Cancer (2021 Edition) [M]. Beijing: People's Medical Publishing House, 2021. |
| Result | Blot, W. J. & Tarone, R. E. Esophageal cancer. Nat Rev Dis Prim. 3, 17048 (2017). |
| 39511164 | Derived | Li N, Xia J, Gao X, Zhou J, Hong Y, Cui D, Zhao X, Wu T, Guo Y, Wang J, Luo S. First-line benmelstobart plus anlotinib and chemotherapy in advanced or metastatic/recurrent esophageal squamous cell carcinoma: a multi-center phase 2 study. Signal Transduct Target Ther. 2024 Nov 8;9(1):303. doi: 10.1038/s41392-024-02008-7. |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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