SBRT With S1 Combined With Endostar in the Treatment of Lung Cancer (SBRTLCES)

March 17, 2020 updated by: Peking University Third Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Cancer Hospital
        • Contact:
          • Huiming Yu
      • Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences
        • Contact:
          • Wenyang Liu
      • Beijing, China
        • China-Japan Friendship Hospital
        • Contact:
          • Meng Liu
      • Beijing, China
        • Peking University International Hospital
        • Contact:
          • Jidong Wang
    • Beijing
      • Beijing, Beijing, China, 100000
        • Peking University Third Hospital
        • Sub-Investigator:
          • Hongqing Zhuang
        • Sub-Investigator:
          • Yi Chen
        • Sub-Investigator:
          • Bin Qiu
        • Sub-Investigator:
          • Suqing Tian
      • Beijing, Beijing, China, 100000
        • The Fifth Medical Center of PLA General Hospital
    • Guang XI
      • Liuzhou, Guang XI, China
        • Liuzhou Worker's Hospital
        • Contact:
          • Chengjun Feng
    • Guangxi
      • NanNing, Guangxi, China, 530000
        • Guangxi Ruikang Hospital
    • Guizhou
      • GuiYang, Guizhou, China, 550000
        • Third Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
          • Qinghua Zhang
    • Liaoning
      • Dalian, Liaoning, China
        • Dalian Municipal Central Hospital Affiliated Of Dalian Medical University
        • Contact:
          • Nan Wang
      • Panjin, Liaoning, China, 124010
        • GEM flower hospital of Liaohe oil field Tang-Du Hospital
        • Contact:
          • Longhai Shen, M Med
        • Principal Investigator:
          • Long hai Shen, M Med
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Hiser Medical Center of Qingdao
        • Contact:
          • Peng Liu, M Med
    • Shanxi
      • TaiYuan, Shanxi, China, 030000
        • Second Hospital of Shanxi Medical University
        • Contact:
        • Sub-Investigator:
          • Lei Zhang, M Med
        • Sub-Investigator:
          • Xiang Song, M Med
      • Xian, Shanxi, China, 710000
        • Tangdu Hospital
        • Contact:
          • DongJie He, M Med
    • Sichuan
      • Mianyang, Sichuan, China, 621000
        • Mianyang Central Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Xiaobo Du, MD
        • Sub-Investigator:
          • Jie Li, M Med

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: experimental group
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
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.
Other Names:
  • S1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OS
Time Frame: 3 years
Overall survival
3 years
PFS
Time Frame: the time interval of disease progression since the date of diagnosis
Progression-free survival
the time interval of disease progression since the date of diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LCR
Time Frame: 2 years
Local control rate criteria for short-term efficacy.
2 years
Adverse reactions
Time Frame: 2 years
adverse events and laboratory tests were graded according to NCI CTC AE 5.0
2 years
Qol
Time Frame: 2 years
Quality of life
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Collaborators

Liuzhou Workers Hospital
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing 302 Hospital
Peking University Cancer Hospital & Institute
Peking University International Hospital
China-Japan Friendship Hospital
Tang-Du Hospital
The Affiliated Hospital of Xuzhou Medical University
Second Hospital of Shanxi Medical University
Mianyang Central Hospital
Qingdao Hiser Medical Group
Guangxi Ruikang Hospital
Third Affiliated Hospital of Guizhou Medical University
Panjin Liaohe Oilfield Gem Flower Hospital
Dalian municipal central hospital affiliated of dalian medical university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

January 30, 2022

Study Completion (ANTICIPATED)

January 30, 2023

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 15, 2020

First Posted (ACTUAL)

February 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-CKES-LUNG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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