drugset / Trial / NCT05262335
Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis (ALTER-G-001)
Phase 2
Unknown
116 enrolled
Ruijin Hospital
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2021-12-01
- Primary completion
- 2023-12-01
- Completion
- 2024-12-01
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 500 mg | Oral |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Subject | Cisplatin | Other / unclassified | 60 mg/m2 | Intravenous |
| Subject | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Subject | Paclitaxel | Small molecule | 135 mg/m2 | Intravenous |