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| Name | Class |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | INDUSTRY |
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This is an open, multi-cohort, multi-center, exploratory and phase II clinical trial. To evaluate the efficacy and safety Anlotinib combined with chemotherapy as first-line and maintenance therapy for Gastrointestinal Tumors with Unresectable Liver Metastases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Experimental group 1 | Experimental | Initial treatment: Anlotinib + Oxaliplatin + Capecitabine. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
|
| Experimental: Experimental group 2 | Experimental | Initial treatment: Anlotinib + Cisplatin + Paclitaxel/ Docetaxel. Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
|
| Experimental: Experimental group 3 | Experimental | Initial treatment: Anlotinib + Standard first-line chemotherapy Maintenance treatment (after 6 cycles): Anlotinib + Capecitabine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib + Oxaliplatin + Capecitabine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate is defined as the percentage of subjects whose best response was complete response (CR) or partial response (PR) according to the RECIST v1.1. | up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival is defined as the time from enrollment to the date of first document disease progression or death from any cause. | up to 24 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with active bleeding within 2 months of primary and/or metastatic lesions;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Zhang, Ph. D | Contact | +86-21-64370045 | junzhang10977@sjtu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39648217 | Derived | Wu JW, Zhou CF, Han ZX, Zhang H, Yan J, Chen J, Wang CB, Qin ZQ, Mao Y, Tang XY, Zhu LJ, Wei XW, Cui DH, Yang XL, Shi M, Zhao LQ, Jiang JL, Zhu WY, Wang HM, Wang C, Zhu LJ, Zhang J. Anlotinib plus chemotherapy as a first-line treatment for gastrointestinal cancer patients with unresectable liver metastases: a multicohort, multicenter, exploratory trial. Signal Transduct Target Ther. 2024 Dec 9;9(1):344. doi: 10.1038/s41392-024-02051-4. | |
| 38515149 |
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|
| Anlotinib + Cisplatin + Paclitaxel/ Docetaxel | Drug |
|
|
| Anlotinib + Standard first-line chemotherapy | Drug |
|
|
Disease control rate is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1.
| up to 24 months |
| Duration of Response (DoR) | Duration of Response is defined as the percentage of subjects whose best response was CR, PR or stable disease (SD) according to the RECIST v1.1 or death due to any cause, whichever occurs first. | up to 24 months |
| Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0). | Until 30 day safety follow-up visit |
| Overall Survival (OS) | Overall Survival (OS) is defined as the time from enrollment to death from any cause. | Up to 24 months |
| Radical Resection Rate of Liver Metastases | Radical Resection Rate of Liver Metastases is defined as the percentage of subjects whose liver metastases from unresectable to resectable. | Up to 6 cycles |
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
|
| Affiliated Hospital of Jiannan University | Not yet recruiting | Wuxi | Jiangsu | China |
|
| Wuxi Branch of Rujin Hospital | Recruiting | Wuxi | Jiangsu | China |
|
| Jiading Cental Hospital Shanghai University of Medicine & Health Sciences | Recruiting | Shanghai | China |
|
| Ruijin Hospital | Recruiting | Shanghai | China |
|
| Tongji Hospital of Tongji University | Not yet recruiting | Shanghai | China |
|
| Derived |
| Li H, Feng H, Zhang T, Wu J, Shen X, Xu S, Xu L, Wang S, Zhang Y, Jia W, Ji X, Cheng X, Zhao R. CircHAS2 activates CCNE2 to promote cell proliferation and sensitizes the response of colorectal cancer to anlotinib. Mol Cancer. 2024 Mar 21;23(1):59. doi: 10.1186/s12943-024-01971-7. |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| D002945 | Cisplatin |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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