| Objective:This study was to investigate the short-term efficacy,long-term efficacy,safety,and quality of life of caffeic acid versus placebo in patients with advanced or recurrent esophageal squamous cell carcinoma in China.Methods:This study was initiated by our hospital and carried out a series of preparatory work in the early stage of clinical trials,such as the initiation of clinical trials in multiple regions,commissioning of third-party institutions to provide the caffeic acid and placebo drugs required for the trial,and Pre-tests to assess drug safety and patient compliance.From October 2018 to March 2019,the clinical trial was conducted at multiple clinical research centers at the same time.Patients with advanced/recurrent esophageal squamous cell carcinoma who met the inclusion criteria were selected,and patients who met the inclusion criteria were informed about clinical trials.Group patients were signed with informed consent.The immunohistochemical detection of GASC1 was performed on the tissue slides of the patients.The GASC1 positive group and the GASC1 negative group were randomly divided into two groups,namely the experimental group(caffeic acid group): the caffeic acid tablets were given.: 0.3g / time,3 times / day,oral,long-term oral medication,until the emergence of intolerable side effects;control group(placebo group): placebo tablets: 0.3g / time,3 times / Day,oral,long-term oral medication,until the emergence of intolerable side effects.The GASC1 negative group was randomly divided into two groups,namely the experimental group(caffeic acid group): the administration of caffeic acid tablets: 0.3 g/time,3 times/day,orally,requiring long-term oral administration until the inability to tolerate toxic side effects;control group(placebo group): placebo tablets: 0.3g / time,3 times / day,oral,long-term oral administration,until the occurrence of intolerable side effects.The imaging data and quality of life scale were reviewed every 8 weeks for questionnaires.The hematology general items were reviewed regularly,and hematological adverse events were recorded.Regular follow-ups were performed once a week to record symptomatic adverse events and overall survival.Statistical analysis was performed on clinical data and experimental data using chi-square test or Fisher's exact test,T test,and rank sum test in statistical methods.The above statistical methods were analyzed by SPSS 23.0 statistical software.P<0.05 indicated that the difference was statistically significant.4.Review the imaging data and quality of life scale every 8 weeks for questionnaires,regularly review general items such as blood routine,biochemistry,and urine routine,record adverse hematological events,and follow up regularly,once a week to record symptomatic adverse events and survival.Results:1.In this study,25 patients were enrolled in the study.According to the results of GASC1 test,11 cases were in GASC1 positive group and 14 cases in GASC1 negative group.The current clinical trial is still in progress,and the clinical unexplained blindness cannot be performed according to the test drug.Grouping,grouping was temporarily grouped by GASC1 test results,and there was no statistically significant difference in baseline characteristics between the two groups.2.The total adverse events mainly include hypotension,esophageal pain,hemoglobin reduction,red blood cell reduction,lymphopenia,leukopenia,hypoalbuminemia,fibrinogen increase,D-dimer elevation,etc.,did not occur 3/ Grade 4 adverse events,drug safety is good.3.The 90-day overall survival rate of the GASC1-positive group was 50%;the 90-day overall survival rate of the GASC1-negative group was 81.8%.The difference in overall survival between the two groups was not revealed due to clinical trials(P = 0.168).4.At present,the clinical trials have not been unblinded,and it is not possible to evaluate the efficacy of the drug and the quality of life before and after administration of the caffeic acid group.Only the baseline and the total quality of life after administration,the baseline of the GASC1 negative group and the quality of life after administration,baseline and medication There was no significant difference in postlife quality(P > 0.05).Conclusions:1.No adverse events of grade 3/4 occurred in the test patients,and the drug safety was good.2.The difference in overall survival between the GASC1-positive group and the GASC1-negative group was not revealed due to clinical trials,and no statistical significance was currently available(P = 0.168).3.The current clinical trial is still in progress.The clinical trial has not been unblinded.It is impossible to evaluate the efficacy and quality of life of caffeic acid versus placebo in patients.The total quality of life and GASC1 negative only at baseline and 8 weeks after administration.There was no significant difference in the quality of life between the baseline and the quality of life at 8 weeks after administration(P > 0.05). |
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