Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

Shanghai Pulmonary Hospital, Shanghai, China

Status: Unknown

Conditions: Safety Issues; Effect Increased

Treatments: Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy; Procedure: bronchoscopic microwave intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04360655

Surpass

Details and patient eligibility

About

A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Full description

This study is a randomized, prospective study, which will analyze the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy

Exclusion criteria

• contraindications to tracheoscopy, chemotherapy, and immunotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Active Comparator group

Description:

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Treatment:

Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

combined with bronchoscopic microwave intervention

Experimental group

Description:

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Treatment:

Procedure: bronchoscopic microwave intervention

Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy