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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

March 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

February 10, 2020

Last Update Submit

March 17, 2020

Conditions

Radiotherapy Side Effect

Keywords

lung cancer, SBRT, s1,endostar

Outcome Measures

Primary Outcomes (2)

  • OS

    Overall survival

    3 years

  • PFS

    Progression-free survival

    the time interval of disease progression since the date of diagnosis

Secondary Outcomes (3)

  • LCR

    2 years

  • Adverse reactions

    2 years

  • Qol

    2 years

Study Arms (1)

experimental group

EXPERIMENTAL

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.

Drug: Endostar

Interventions

EndostarDRUG

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.

Also known as: S1
experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lung squamous cell carcinoma was confirmed by histopathology or cytopathology;
  • Meet AJCC(8th edition, 2018) lung cancer stage IV standard;
  • Lesions requiring SBRT;
  • 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);
  • Age \>=18 years old;
  • KPS \> = 70;
  • Life expectancy of at least 3 months;
  • Hematology, liver and kidney function and cardiopulmonary function can tolerate radiotherapy and chemotherapy.

You may not qualify if:

  • Lung adenocarcinoma or small cell lung cancer;
  • Previous immunotherapy;
  • Patients at risk of bleeding;
  • Patients with any other malignant tumor before or now
  • Patients diagnosed with esophagotracheal fistula,uncontrolled pleural effusion,pericardial effusion requiring repeated drainage,unhealed wounds,active gastric ulcers or fractures
  • 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;
  • Patients with known central nervous system metastases.
  • 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.
  • Pregnant or breastfeeding women;Women and men who are likely to become pregnant but do not want to use appropriate contraception;
  • Other circumstances in which the investigator decides not to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Peking University Third Hospital

Beijing, Beijing Municipality, 100000, China

Location

The fifth medical center of PLA general hospital

Beijing, Beijing Municipality, 100000, China

Location

Liuzhou Worker's Hospital

Liuchow, Guangxi, China

Location

Guangxi ruikang hospital

Nanning, Guangxi, 530000, China

Location

Third Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Location

Dalian municipal central hospital affiliated of dalian medical university

Dalian, Liaoning, China

Location

GEM flower hospital of Liaohe oil field Tang-Du Hospital

Panjin, Liaoning, 124010, China

Location

Hiser Medical Center of Qingdao

Qingdao, Shandong, 266000, China

Location

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

Location

Tangdu hospital

Xian, Shanxi, 710000, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking University International Hospital

Beijing, China

Location

Related Publications (17)

  • Heist RS, Mino-Kenudson M, Sequist LV, Tammireddy S, Morrissey L, Christiani DC, Engelman JA, Iafrate AJ. FGFR1 amplification in squamous cell carcinoma of the lung. J Thorac Oncol. 2012 Dec;7(12):1775-1780. doi: 10.1097/JTO.0b013e31826aed28.

    PMID: 23154548BACKGROUND

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

  • Crino L, Weder W, van Meerbeeck J, Felip E; ESMO Guidelines Working Group. Early stage and locally advanced (non-metastatic) non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010 May;21 Suppl 5:v103-15. doi: 10.1093/annonc/mdq207. No abstract available.

    PMID: 20555058BACKGROUND

  • Felip E, Stahel RA, Pavlidis N; ESMO Guidelines Task Force. ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of non-small-cell lung cancer (NSCLC). Ann Oncol. 2005;16 Suppl 1:i28-9. doi: 10.1093/annonc/mdi821. No abstract available.

    PMID: 15888743BACKGROUND

  • William WN Jr, Lin HY, Lee JJ, Lippman SM, Roth JA, Kim ES. Revisiting stage IIIB and IV non-small cell lung cancer: analysis of the surveillance, epidemiology, and end results data. Chest. 2009 Sep;136(3):701-709. doi: 10.1378/chest.08-2968. Epub 2009 Mar 24.

    PMID: 19318668BACKGROUND

  • D'Angelo SP, Pietanza MC, Johnson ML, Riely GJ, Miller VA, Sima CS, Zakowski MF, Rusch VW, Ladanyi M, Kris MG. Incidence of EGFR exon 19 deletions and L858R in tumor specimens from men and cigarette smokers with lung adenocarcinomas. J Clin Oncol. 2011 May 20;29(15):2066-70. doi: 10.1200/JCO.2010.32.6181. Epub 2011 Apr 11.

    PMID: 21482987BACKGROUND

  • Socinski MA, Evans T, Gettinger S, Hensing TA, VanDam Sequist L, Ireland B, Stinchcombe TE. Treatment of stage IV non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e341S-e368S. doi: 10.1378/chest.12-2361.

    PMID: 23649446BACKGROUND

  • Johnson DH, Fehrenbacher L, Novotny WF, Herbst RS, Nemunaitis JJ, Jablons DM, Langer CJ, DeVore RF 3rd, Gaudreault J, Damico LA, Holmgren E, Kabbinavar F. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol. 2004 Jun 1;22(11):2184-91. doi: 10.1200/JCO.2004.11.022.

    PMID: 15169807BACKGROUND

  • Scagliotti G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis F, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S, Hanna N. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010 Apr 10;28(11):1835-42. doi: 10.1200/JCO.2009.26.1321. Epub 2010 Mar 8.

    PMID: 20212250BACKGROUND

  • Garon EB, Ciuleanu TE, Arrieta O, Prabhash K, Syrigos KN, Goksel T, Park K, Gorbunova V, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov SV, Lewanski CR, Thomas M, Bidoli P, Dakhil S, Gans S, Kim JH, Grigorescu A, Karaseva N, Reck M, Cappuzzo F, Alexandris E, Sashegyi A, Yurasov S, Perol M. Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. Lancet. 2014 Aug 23;384(9944):665-73. doi: 10.1016/S0140-6736(14)60845-X. Epub 2014 Jun 2.

    PMID: 24933332BACKGROUND

  • Meng MB, Jiang XD, Deng L, Na FF, He JZ, Xue JX, Guo WH, Wen QL, Lan J, Mo XM, Lang JY, Lu Y. Enhanced radioresponse with a novel recombinant human endostatin protein via tumor vasculature remodeling: experimental and clinical evidence. Radiother Oncol. 2013 Jan;106(1):130-7. doi: 10.1016/j.radonc.2012.10.022. Epub 2013 Jan 23.

    PMID: 23351845BACKGROUND

  • Masuda T, Watanabe M, Fujitaka K, Hamai K, Ishikawa N, Doi M, Kitaguchi S, Yamaguchi K, Sakamoto S, Horimasu Y, Miyamoto S, Nakashima T, Senoo T, Iwamoto H, Hamada H, Hattori N. Alternate-day administration of S-1 for elderly patients with advanced non-small-cell lung carcinoma: A prospective feasibility study. Mol Clin Oncol. 2018 Nov;9(5):539-544. doi: 10.3892/mco.2018.1705. Epub 2018 Aug 24.

    PMID: 30345049BACKGROUND

  • Iwamoto Y, Mitsudomi T, Sakai K, Yamanaka T, Yoshioka H, Takahama M, Yoshimura M, Yoshino I, Takeda M, Sugawara S, Kawaguchi T, Takahashi T, Ohta M, Ichinose Y, Atagi S, Okada M, Saka H, Nakagawa K, Nakanishi Y, Nishio K. Randomized Phase II Study of Adjuvant Chemotherapy with Long-term S-1 versus Cisplatin+S-1 in Completely Resected Stage II-IIIA Non-Small Cell Lung Cancer. Clin Cancer Res. 2015 Dec 1;21(23):5245-52. doi: 10.1158/1078-0432.CCR-14-3160. Epub 2015 Aug 7.

    PMID: 26253869BACKGROUND

  • Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y, Fukuoka M. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol. 2007 Feb;18(2):317-23. doi: 10.1093/annonc/mdl377. Epub 2006 Nov 1.

    PMID: 17079694BACKGROUND

  • Yamashita Y, Kataoka K, Ishida T, Matsuura M, Seno N, Mukaida H, Miyahara E, Miyata Y, Okita R, Shimizu K, Watari M, Okumichi T, Okada M. A feasibility study of postoperative adjuvant therapy of carboplatin and weekly paclitaxel for completely resected non-small cell lung cancer. J Thorac Oncol. 2008 Jun;3(6):612-6. doi: 10.1097/JTO.0b013e318174e05e.

    PMID: 18520800BACKGROUND

  • Sugaya M, Uramoto H, Uchiyama A, Nagashima A, Nakanishi R, Sakata H, Nakanishi K, Hanagiri T, Yasumoto K. Phase II trial of adjuvant chemotherapy with bi-weekly carboplatin plus paclitaxel in patients with completely resected non-small cell lung cancer. Anticancer Res. 2010 Jul;30(7):3039-44.

    PMID: 20683052BACKGROUND

  • Nishio M, Horai T, Horiike A, Nokihara H, Yamamoto N, Takahashi T, Murakami H, Yamamoto N, Koizumi F, Nishio K, Yusa W, Koyama N, Tamura T. Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer. Br J Cancer. 2013 Aug 6;109(3):538-44. doi: 10.1038/bjc.2013.374. Epub 2013 Jul 16.

    PMID: 23860537BACKGROUND

MeSH Terms

Conditions

Radiation InjuriesLung Neoplasms

Interventions

endostar proteinS 1 (combination)

Condition Hierarchy (Ancestors)

Wounds and InjuriesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2020

First Posted

February 18, 2020

Study Start

April 1, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2023

Last Updated

March 19, 2020

Record last verified: 2020-02

Locations

CN(16)