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

Not Applicable

• Conditions: Radiotherapy Side Effect
• Interventions: Drug: Endostar

• Registration Number: NCT04274270
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-10
• Study First Submitted QC: 2020-02-15
• Study First Posted: 2020-02-18
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19
• Study Start: 2020-04-01
• Primary Completion: 2022-01-30
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental group	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.

Primary Outcome Measures

Name	Time	Method
OS	3 years	Overall survival
PFS	the time interval of disease progression since the date of diagnosis	Progression-free survival

Secondary Outcome Measures

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

Trial Locations

Locations (16)

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

GEM flower hospital of Liaohe oil field Tang-Du Hospital; 🇨🇳 Panjin, Liaoning, China

Hiser Medical Center of Qingdao; 🇨🇳 Qingdao, Shandong, China

Tangdu hospital; 🇨🇳 Xian, Shanxi, China

Mianyang Central Hospital; 🇨🇳 Mianyang, Sichuan, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Peking University International Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Third Affiliated Hospital of Guizhou Medical University; 🇨🇳 GuiYang, Guizhou, China

Liuzhou Worker's Hospital; 🇨🇳 Liuzhou, Guang XI, China

Guangxi ruikang hospital; 🇨🇳 NanNing, Guangxi, China

The fifth medical center of PLA general hospital; 🇨🇳 Beijing, Beijing, China

Dalian municipal central hospital affiliated of dalian medical university; 🇨🇳 Dalian, Liaoning, China

Second hospital of Shanxi Medical University; 🇨🇳 TaiYuan, Shanxi, China

Beijing Cancer Hospital; 🇨🇳 Beijing, China