SBRT With S1 Combined With Endostar in the Treatment of Lung Cancer

• Status: Not yet recruiting
• Trial end date: 2023-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Peking University Third Hospital
• Collaborators: Beijing 302 Hospital; Beijing Cancer Hospital; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; China-Japan Friendship Hospital; Dalian municipal central hospital affiliated of dalian medical university; GEM flower hospital of Liaohe oil field; Guangxi Ruikang Hospital; Hiser Medical Center of Qingdao; Liuzhou Worker's Hospital; Liuzhou Workers Hospital; Mianyang Central Hospital; Panjin Liaohe Oilfield Gem Flower Hospital; Peking University International Hospital; Qingdao Hiser Medical Group; Second Hospital of Shanxi Medical University; Tang-Du Hospital; The Affiliated Hospital of Xuzhou Medical University; The fifth medical center of PLA general hospital; Third Affiliated Hospital of Guizhou Medical University
• Treatments: Endostar protein

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.