BAI-BACE for Advanced Lung Squamous Cell Carcinoma

NCT ID: NCT06377735

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-30

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.

Conditions

Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BAI-BACE

Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI)

Group Type: EXPERIMENTAL

BAI-BACE

Intervention Type: PROCEDURE

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.

Interventions

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 the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhou Qunfang

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feng Duan, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Chinese PLA General hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qunfang Zhou, MD

Role: CONTACT

zhouqun988509@163.com

86 19868000115

Feng Duan, MD

Role: CONTACT

duanfeng@vip.sina.com

86 13910984586

Facility Contacts

Qunfang Zhou, MD

Role: primary

zhouqun988509@163.com

8619868000115

Feng Duan, MD

Role: backup

duanfeng@vip.sina.com

8613910984586

Other Identifiers

CHEST-001

Identifier Type: -

Identifier Source: org_study_id