To compare the effects and safety of Anlotinib Plus Irinotecan versus Irinotecan in patients with esophageal squamous cell carcinoma(ESCC).
In recent years, anti-angiogenic therapy has made some progress in the treatment of advanced esophageal squamous cell carcinoma.In clinical use, the efficacy of antiangiogenic monotherapy was low, with a median progression-free survival (PFS) of only 3 to 4 months.We conducted a randomized, open clinical Trial to evaluate efficacy and safety of anlotinib hydrochloride combined with irinotecan versus irinotecan monotherapy in patients with advanced esophageal squamous cell carcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.
Irinotecan Day 1,8 ivgtt
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGProgress free survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm.
Time frame: up to 24 months
Disease Control Rate (DCR)
The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR \+ PR + SD)
Time frame: up to 24 months
Overall Survival (OS)
The time from treatment initiation until death from any reason
Time frame: up to 24 months
Objective Response Rate (ORR)
The proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: up to 24 months
Quality of life score
Each 42 days up to intolerance the toxicity or PD
Time frame: up to 24 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Until initiation of new anticancer treatment
Time frame: up to 24 months
NGS(Next Generation Sequencing) detecting
The sample for NGS detecting can be gotten form storage tumor tissue specimens. It must be better collecting the new tumor tissue specimens after tumor progress
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Time frame: up to 12 months