BAI-BACE for Advanced Lung Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: BAI-BACE.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Bronchial Arterial Infusion Plus Bronchial Arterial Chemoembolization (BAI-BACE) for Advanced Lung Squamous Cell Carcinoma: a Multicenter Single-arm Phase II Study
Overview
Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported as non-first-line therapy to treat lung cancer in many hospitals in China. BAI, which uses chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. In this study, we aim to describe the efficacy and safety of BAI-BACE as non-first-line for advanced lung squamous cell carcinoma.
Detailed description
This study is a multicenter, interventional study to explore the efficacy, safety of BAI-BACE as non-first-line therapy for advanced central squamous cell carcinoma. Lung cancer is the leading cause of cancer-related death worldwide. Owing to the insidious symptom, most patients (about 75 %) are diagnosed at the advanced stage of the disease and, thus, cannot undergo resection. The central squamous cell carcinoma accounts for 25% of all cases of lung cancer. The first-line standard treatment for advanced central squamous cell carcinoma is combined chemoradiotherapy, and chemoradiotherapy is usually as the second-line. However, treatment failure is noted in many patients, and those patients often face the limited therapy choice and poor prognosis. Bronchial arterial infusion plus bronchial arterial chemoembolization (BAI-BACE) has been reported to treat lung cancer in many hospitals in China. BAI, which use chemotherapeutic drugs directly injected into the tumor and achieved a high concentration in a short time to kill the tumor. Then BACE could seal off the tumor vessels. The systemic toxicity of this surgery is low and tolerable. This study will provide clinical evidence that BACE-BAI will provide survival benefit for patients with advanced central squamous cell carcinoma.
Interventions
- Procedure BAI-BACE
Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI) procedure was performed as follows: Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, paclitaxel (300 mg) was infused slowly at least 30 min. BAI (bronchial arterial infusion) chemotherapy was followed by BACE (Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with cis-platinum (30 mg) were infused into
Primary outcome measures
- Progression-Free-Survival (PFS) [Time frame: 12 months]
Secondary outcome measures (3)
- Overall survival (OS) [Time frame: 24 months]
- Objective response rate (ORR) [Time frame: 12 months]
- Adverse events [Time frame: 24 months]
Eligibility criteria
Inclusion criteria
- Squamous cell carcinoma diagnosed by pathology, and central location by imaging;
- Age 18-80;
- Patients failed to the standard first-line or second-line treatment;
- Tumors limited in the chest;
- Tumors were fed by bronchial artery through CTA reconstruction;
- Patents received PD-1 inhibitor or not were also included;
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2;
- Images within 2 weeks before inclusion;
- Life expectancy more than 3 months;
- Agreed to participated in this clinical trial;
- Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.
Exclusion criteria
- Contraindication of BAI or BACE;
- Under 18 years or over 75 years;
- extra-chest metastases;
- Receiving other antitumor treatment;
- Severe infection or pregnancy;
- Severe Pulmonary fibrosis and pulmonary artery;
- liver, kidney or poor physical conditions;
- Severe pleural effusion or pericardial effusion;
- Life expectancy less than 3 months.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General hospital — Beijing
Identifiers
NCT: NCT06377735 · CHEST-001