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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
1. Before 6 cycles, Anlotinib 12mg, po.qd, d1-14; Capecitabine 850 mg/m2, po. bid, d1-14; Oxaliplatin 130 mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
1. Anlotinib 12mg, po.qd, d1-14; Cisplatin 60-75mg/m2, iv, d1/d1-d3; Paclitaxel 135mg/m2, iv (D1). or Docetaxel 75mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGJiangsu Province Hospital
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGAffiliated Hospital of Jiannan University
Wuxi, Jiangsu, China
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.
Time frame: up to 24 months
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.
Time frame: up to 24 months
Disease Control Rate (DCR)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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1. Anlotinib 12mg, po.qd, d1-14; Standard first-line chemotherapy determined by the researchers. The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
Wuxi Branch of Rujin Hospital
Wuxi, Jiangsu, China
RECRUITINGJiading Cental Hospital Shanghai University of Medicine & Health Sciences
Shanghai, China
RECRUITINGRuijin Hospital
Shanghai, China
RECRUITINGTongji Hospital of Tongji University
Shanghai, China
NOT_YET_RECRUITINGTime frame: Up to 6 cycles