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

Immune targeted brachytherapy in tumor with microwave ablation therapy for lung cancer--a multiple centres post-market, open, randomised controlled clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10001040

Enrollment

Unknown

Registered

2010-03-12

Start date

2009-12-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

local advanced NSCLC

Interventions

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.

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Safety;Tumor markers;survival;	—

Countries

China

Contacts

Public ContactZhang Jiren

zhangjiren@126.com+86 020 61643200

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026