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Trial Title:
BAI-BACE for Advanced Lung Squamous Cell Carcinoma
NCT ID:
NCT06377735
Condition:
Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Conditions: Keywords:
bronchial arterial infusion
bronchial arterial chemoembolization
paclitaxel
CalliSpheres
cis-platinum
advanced central squamous cell carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
BAI-BACE
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.
Arm group label:
BAI-BACE
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Chinese PLA General hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Qunfang Zhou, MD
Phone:
8619868000115
Email:
zhouqun988509@163.com
Contact backup:
Last name:
Feng Duan, MD
Phone:
8613910984586
Email:
duanfeng@vip.sina.com
Start date:
May 1, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06377735
