Squamous Cell Carcinoma
Conditions
Keywords
bronchial arterial infusion, bronchial arterial chemoembolization, paclitaxel, CalliSpheres, cis-platinum, advanced central squamous cell carcinoma
Brief summary
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
PROCEDUREBAI-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 the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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 the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Squamous cell carcinoma diagnosed by pathology, and central location by imaging; 2. Age 18-80; 3. Patients failed to the standard first-line or second-line treatment; 4. Tumors limited in the chest; 5. Tumors were fed by bronchial artery through CTA reconstruction; 6. Patents received PD-1 inhibitor or not were also included; 7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-2; 8. Images within 2 weeks before inclusion; 9. Life expectancy more than 3 months; 10. Agreed to participated in this clinical trial; 11. 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
1. Contraindication of BAI or BACE; 2. Under 18 years or over 75 years; 3. extra-chest metastases; 4. Receiving other antitumor treatment; 5. Severe infection or pregnancy; 6. Severe Pulmonary fibrosis and pulmonary artery; 7. liver, kidney or poor physical conditions; 8. Severe pleural effusion or pericardial effusion; 9. Life expectancy less than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival (PFS) | 12 months | Progression was defined as progressive disease by independent radiologic review |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 24 months | OS is the length of time from the date of inclusion until death from any cause. |
| Objective response rate (ORR) | 12 months | ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response. |
| Adverse events | 24 months | Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, MD
Outcome results
None listed