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Brief Title: SBRT With S1 Combined With Endostar in the Treatment of Lung Cancer
Official Title: Safety and Efficacy of Sequential Stereotactic Radiotherapy With S1 Combined With Endostar in the Treatment of Stage IV Lung Squamous Cell Carcinoma: Prospective, Multicenter, Exploratory Study
Study ID: NCT04274270
Brief Summary: Human recombinant endostatin preclinical studies have shown that the drug can inhibit endothelial cell proliferation, angiogenesis and tumor growth, still can directly induce lung cancer cell apoptosis, multiple clinical studies in human recombinant endostatin combined with chemotherapy treatment showed good antitumor efficacy and good safety.S1 is an oral fluorouracil derivative and an improved preparation of the antitumor drug tegafur.Multiple clinical studies have reported that S1 alone or S1 combined with chemotherapy is effective in Non small cell lung cancer(NSCLC).Unfortunately, none of the prospective clinical studies to date have systematically validated the safety and efficacy of antiangiogenic drugs combined with chemotherapy in patients with advanced pulmonary SCC.The investigators expect that endu combined with S1 will increase the efficacy of advanced lung squamous cell carcinoma.The purpose of this study was to evaluate the objective remission rate and safety of entu combined with oral S1 in the treatment of advanced lung squamous cell carcinoma.
Detailed Description: In this study, the investigatorse enrolled patients with advanced lung squamous cell carcinoma to explore the safety and efficacy of sequential local radiotherapy combined with endodontic therapy.Plan to enroll 60 cases.For those who meet the inclusion criteria, medical history collection, physical examination, hematological examination and general imaging examination shall be completed before inclusion.Radiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.Treatment-related toxicity, treatment response and survival were followed up during treatment.Drug treatment until the tumor progresses, or there is an intolerable treatment-related toxicity, or no tolerance to further treatment.The treatment lasts for up to 3 years with good toxicity tolerance.During the treatment, the dose of teggio and endu is not adjusted. If serious adverse reactions occur, the drug should be treated actively and delayed.If the investigator determines that the treatment-related toxicity cannot be tolerated, the treatment is discontinued.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Peking University Third Hospital, Beijing, Beijing, China
The fifth medical center of PLA general hospital, Beijing, Beijing, China
Liuzhou Worker's Hospital, Liuzhou, Guang XI, China
Guangxi ruikang hospital, NanNing, Guangxi, China
Third Affiliated Hospital of Guizhou Medical University, GuiYang, Guizhou, China
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China
Dalian municipal central hospital affiliated of dalian medical university, Dalian, Liaoning, China
GEM flower hospital of Liaohe oil field Tang-Du Hospital, Panjin, Liaoning, China
Hiser Medical Center of Qingdao, Qingdao, Shandong, China
Second hospital of Shanxi Medical University, TaiYuan, Shanxi, China
Tangdu hospital, Xian, Shanxi, China
Mianyang Central Hospital, Mianyang, Sichuan, China
Beijing Cancer Hospital, Beijing, , China
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, , China
China-Japan Friendship Hospital, Beijing, , China
Peking University International Hospital, Beijing, , China