Clinical trial NCT04274270: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Radiotherapy Side Effect
Keywords: lung cancer, SBRT, s1,endostar
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Mianyang Central Hospital
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Peking University Cancer Hospital & Institute
name: Peking University International Hospital
name: China-Japan Friendship Hospital
name: Beijing 302 Hospital
name: Second Hospital of Shanxi Medical University
name: Qingdao Hiser Medical Group
name: Guangxi Ruikang Hospital
name: Panjin Liaohe Oilfield Gem Flower Hospital
name: Tang-Du Hospital
name: Third Affiliated Hospital of Guizhou Medical University
name: Liuzhou Workers Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Dalian municipal central hospital affiliated of dalian medical university
First posted: 2020-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Lung squamous cell carcinoma was confirmed by histopathology or cytopathology;
2. Meet AJCC(8th edition, 2018) lung cancer stage IV standard;
3. Lesions requiring SBRT;
4. Measurable lesions must have at least one evaluable lesion judged according to RECIST 1.1 standard, i.e., the longest diameter is at least 20mm);
5. Age \>=18 years old;
6. KPS \> = 70;
7. Life expectancy of at least 3 months;
8. Hematology, liver and kidney function and cardiopulmonary function can tolerate radiotherapy and chemotherapy.

Exclusion Criteria:

1. Lung adenocarcinoma or small cell lung cancer;
2. Previous immunotherapy;
3. Patients at risk of bleeding;
4. Patients with any other malignant tumor before or now
5. Patients diagnosed with esophagotracheal fistula,uncontrolled pleural effusion,pericardial effusion requiring repeated drainage,unhealed wounds,active gastric ulcers or fractures
6. Patients suffering from poorly controlled heart disease or clinical symptoms, such as NYHA grade II or above cardiac dysfunction;unstable angina pectoris;Myocardial infarction occurred within 1 year;supraventricular or ventricular arrhythmia needs treatment or intervention;
7. Patients with known central nervous system metastases.
8. Patients with clinically suspected central nervous system metastasis must undergo enhanced CT or MRI within 28 days prior to randomization to exclude central nervous system metastasis.
9. Pregnant or breastfeeding women;Women and men who are likely to become pregnant but do not want to use appropriate contraception;
10. Other circumstances in which the investigator decides not to participate in this study.

Primary outcomes:
measure: OS
timeFrame: 3 years
measure: PFS
timeFrame: the time interval of disease progression since the date of diagnosis
Secondary outcomes:
measure: LCR
timeFrame: 2 years
measure: Adverse reactions
timeFrame: 2 years
measure: Qol
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: The fifth medical center of PLA general hospital
state: Beijing
city: Liuzhou
country: China
facility: Liuzhou Worker's Hospital
state: Guang XI
city: NanNing
country: China
facility: Guangxi ruikang hospital
state: Guangxi
city: GuiYang
country: China
facility: Third Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Dalian
country: China
facility: Dalian municipal central hospital affiliated of dalian medical university
state: Liaoning
city: Panjin
country: China
facility: GEM flower hospital of Liaohe oil field Tang-Du Hospital
state: Liaoning
city: Qingdao
country: China
facility: Hiser Medical Center of Qingdao
state: Shandong
city: TaiYuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
city: Xian
country: China
facility: Tangdu hospital
state: Shanxi
city: Mianyang
country: China
facility: Mianyang Central Hospital
state: Sichuan
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University International Hospital
Study officials:
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