A clinical trial of immune targeted brachytherapy in tumor with microwave ablation therapy for lung cancer

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-10001040
• Date of registration: 2010-03-12
• Prospective Registration: No
• Primary sponsor: ZhuJiang Hospital Affiliated to Southern Medical University
• Public title: A clinical trial of immune targeted brachytherapy in tumor with microwave ablation therapy for lung cancer
• Scientific title: Immune targeted brachytherapy in tumor with microwave ablation therapy for lung cancer--a multiple centres post-market, open, randomised controlled clinical trial
• Date of first enrolment: 2009-12-01
• Target sample size: A:700;B:700;C:600;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=8498
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Ding Weimin
• Affiliation: Zhujiang Hospital Affiliated to Southern Medical University

• Name: Zhang Jiren

Key inclusion & exclusion criteria

Inclusion criteria: 1. lung cancer with the definite pathology diagnosis, including initial treatment and relapse cases;
2. with mensurability focus for evaluate (diameter>1cm in CT);
3. lung cacer with local treatment indication(local advanced NSCLC; distant metastasis NSCLC that can relieve the symptom or reduce the tumor with local treatment; refractory NSCLC that can relieve the symptom or reduce the tumor with local treatment; early stage NSCLC refuse the surgery for non-medical reason(T1-3,N0M0));
4. dose not receive radiotherapy, chemotherapy or moleculartargeted treatment within 3 weeks;
5. cardiopulmonary function is almost normal;
6. male and female, ages 18 to 70 years;
7. prediction survival period>3 months;
8. Karnofsky =70;
9. patients and relatives have the ability to understand the requirements of the study, provide written informed consent to participate
Exclusion criteria: 1. pregnant and/or breastfeeding, or planning to have any children;
2. serious heart, liver and kindey dysfunction;
3. allergic reaction to iodin and positive TNT antibody test;
4. normal blood test: wbc<4.0*10^9/L. or PLT<80*10^9/L;
5. having received murine origine antibody treatment;
6. acute infection and acute stage in chronic infection;
7. thyroid function is obviously abnormal;
8. serious pleural effusion and ascites;
9. psychosis, history of mental disease, can not willingness to follow the treatment;
10. participation in a study of another device or drug within 3 month;
11. blood coagulation dysfunction;
12. tumor is close to important organ which might make it unsafe for microwave ablation therapy;
13. as per the Investigator's discretion, it is not suitable to participate in this study.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

local advanced NSCLC; distant metastasis NSCLC and refractory NSCLCthat can relieve the symptom or reduce the tumor with local treatment; early stage NSCLC refuse the surgery for non-medical reason

Intervention(s)

A:microwave ablation with Vivatuxin (131l-chTNT) immune targeted brachytherapy: microwave ablation in d1; Vivatuxin (131l-chTNT) intra-tumor injectionin d5 (dosage 18.5-37.0 MBq (0.5 mCi)/cm3 volume,most dosage is) 1850 MBq (50 mCi), evaluate the recent effect in d33.;B:microwave ablation: microwave ablation in d1; evaluate the recent effect in d33.;C:Vivatuxin (131l-chTNT) immune targeted brachytherapy: Vivatuxin (131l-chTNT) intra-tumor injectionin d5, evaluate the recent effect in d33.;

Primary Outcome(s)

Safety;Tumor markers;survival;

Source(s) of Monetary Support

China Ministry of Health Special Found