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

NCT05248022 | Unknown

• 1 other identifier: ZJLS-KLDMIR-21002
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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

Keywords

Non-Small-Cell Lung cancer; Drug-eluting Beads Bronchial Arterial Chemoembolization; PD-1 inhibitor; advanced

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The most common primary endpoint in cancer trials.

  The time from enrollment to tumor progression or death from any cause, whichever came first, measured in "months", assessed up to 2 years.

Secondary Outcomes (11)

• Overall Survival

  Time from randomization to death from any cause, in "months", assessed up to 2 years. For patients who are still alive at the time of data analysis, OS is calculated based on the date when the patient is last known to be alive.

• Time to tumor untreatable progression

  The time interval between randomization to tumor progression that patients are unable to further receive treatment, assessed up to 12 months.

• Objective Response Rate

  Proportion of patients who achieved complete remission (CR) or partial remission (PR) according to mRECIST criteria, assessed up to 12 months.

• Disease Control Rate

  Proportion of patients with complete remission (CR), partial remission (PR), and stable disease (SD) according to mRECIST criteria, assessed up to 12 months.

• Duration of Overall Response

  The time from the first assessment of the tumor as complete remission or partial remission to the first assessment as disease progression or death from any cause, assessed up to 12 months.

Study Arms (2)

Combination Treatment Group

EXPERIMENTAL

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

Procedure: Drug-eluting beads bronchial arterial chemoembolization; Drug: Programmed Cell Death Protein 1 Inhibitor

Single Treatment Group

ACTIVE COMPARATOR

Only receive drug-eluting beads bronchial arterial chemoembolization treatment.

Procedure: Drug-eluting beads bronchial arterial chemoembolization

Interventions

Drug-eluting beads bronchial arterial chemoembolization 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.

Combination Treatment Group; Single Treatment Group

Programmed Cell Death Protein 1 Inhibitor 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.

Combination Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Central Hospital of Lishui City: lead
• Jiangxi Provincial Cancer Hospital: collaborator
• Jiangxi Chest Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Zhejiang University: collaborator

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xihui Ying, MD.

  The Central Hospital of Lishui City

  STUDY DIRECTOR

Central Study Contacts

Jianfei Tu, Dr.

CONTACT

+8613646782878; jianfei1133@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is an open-label study. The Participants and investigators are not blinded, but the outcomes assessor are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: February 21, 2022
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: Within six months after the trial is completed.
• Access Criteria: Shared data is not available for downloading, but can only be browsed. To download the data, you must contact the researchers. Shared data does not provide any private information of the participants.