Efficacy and Safety of DEB-BACE Combined With PD-1 Inhibitors in Stage II/III NSCLC With Standard Treatment Failure

NCT ID: NCT05248022

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-12-31

Brief Summary

This study is a prospective, multi-center, randomized, open-ended, double-arm clinical study. All eligible patients were randomly assigned to DEB-BACE combined with PD-1 inhibitor (Sindilizumab) treatment group (test group) and DEB-BACE treatment group (control group), to explore the efficacy and safety of combination therapy for stage II/III NSCLC with standard treatment failure or intolerable patients.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Combination Treatment Group

Drug-eluting Beads Bronchial Arterial Chemoembolization combined with Programmed Cell Death Protein 1 Inhibitor was used for treatment.

Group Type: EXPERIMENTAL

Drug-eluting beads bronchial arterial chemoembolization

Intervention Type: PROCEDURE

Drug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days.

Programmed Cell Death Protein 1 Inhibitor

Intervention Type: DRUG

Programmed cell death protein 1 inhibitor fixation was treated with sintilimab (Xinda Biopharmaceutical Co., Ltd.). It is administered by intravenous infusion, and the recommended dose is 200 mg, given once every 21 days. The medication will last for two years until disease progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive agents will not be replaced and the dose will not be adjusted.

Single Treatment Group

Only receive drug-eluting beads bronchial arterial chemoembolization treatment.

Group Type: ACTIVE_COMPARATOR

Drug-eluting beads bronchial arterial chemoembolization

Intervention Type: PROCEDURE

Drug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days.

Interventions

Drug-eluting beads bronchial arterial chemoembolization

Drug-eluting beads bronchial arterial chemoembolization generally uses platinum-containing two-drug chemotherapy "platinum (cisplatin, carboplatin, nedaplatin) combined treatment, and drug-loaded microspheres can be loaded with vinorelbine, gemcitabine, irinote Kang, raltitrexed. The dose of chemotherapy drugs is set to 75mg/m2 of platinum, and the dose of chemotherapy through catheter infusion is reduced by 25%. The dose of drug-loaded drugs is vinorelbine 25mg/m2, gemcitabine generally 1000mg/m2, irinotecan 80mg/ m2, raltitrexed 4mg. Chemotherapy was perfused first, followed by embolization with drug-loaded microspheres, until the blood flow in the artery supplying the tumor slowed down and approached stagnation. The number of DEB-BACE treatments is determined by the investigator, and is given as needed according to the patient's condition, usually 1-2 times, with an interval of 28±10 days.

Intervention Type: PROCEDURE

Programmed Cell Death Protein 1 Inhibitor

Programmed cell death protein 1 inhibitor fixation was treated with sintilimab (Xinda Biopharmaceutical Co., Ltd.). It is administered by intravenous infusion, and the recommended dose is 200 mg, given once every 21 days. The medication will last for two years until disease progression or intolerable toxicity occurs. During immunotherapy, immunosuppressive agents will not be replaced and the dose will not be adjusted.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age more than 18 years old, no gender limit.
• According to the Diagnosis and Treatment of Primary Lung Cancer (2018 edition), non-small cell lung cancer (NSCLC) was diagnosed by histopathology.
• Tumor Node Metastasis (TNM) staging is II-III.
• According to the National Comprehensive Cancer Network (NCCN) guidelines, patients who had failed, refused, or were not suitable for standard treatment (surgery, chemoradiotherapy, targeted) after consultation.
• Eastern Cooperative Oncology Group (ECOG), Performance Status (PS) Score ≤ 2.
• Estimated survival time is more than 3 months.
• The patient has signed informed consent.

Exclusion Criteria

• The patient has previously received interventional therapy [iodine seed implantation, ablation, bronchial arterial chemoembolization (BACE) therapy], or received immunotherapy during the first-line standard treatment.
• The patient is accompanied by other malignant tumors and had not been cured.
• White blood cell < 3×10*9/L, absolute value of neutrophils < 1.5×10*9/L, neutrophil/lymphocyte ratio ≥ 3, platelet count < 50×10*9/L, hemoglobin concentration < 90 g/L.
• Liver and kidney dysfunction (creatinine > 176.8 μmol/L; aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 times the upper limit of normal).
• Uncorrectable coagulopathy or active hemoptysis.
• Patient with active infections requires antibiotic treatment.
• Patient has uncontrollable hypertension, diabetes, and cardiovascular disease with obvious symptoms.
• Allergy to contrast agents.
• Women with pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role: collaborator

Jiangxi Chest Hospital

UNKNOWN

Sponsor Role: collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xihui Ying, MD.

Role: STUDY_DIRECTOR

The Central Hospital of Lishui City

Central Contacts

Jianfei Tu, Dr.

Role: CONTACT

jianfei1133@163.com

+8613646782878

Other Identifiers

ZJLS-KLDMIR-21002

Identifier Type: -

Identifier Source: org_study_id