BAI-BACE for Advanced Lung Squamous Cell Carcinoma

NCT06377735 | Recruiting

• 1 other identifier: CHEST-001
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Keywords

bronchial arterial infusion; bronchial arterial chemoembolization; paclitaxel; CalliSpheres; cis-platinum; advanced central squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  Progression was defined as progressive disease by independent radiologic review

  12 months

Secondary Outcomes (3)

• Overall survival (OS)

  24 months

• Objective response rate (ORR)

  12 months

• Adverse events

  24 months

Study Arms (1)

BAI-BACE

EXPERIMENTAL

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

Procedure: BAI-BACE

Interventions

BAI-BACE 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.

BAI-BACE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Chinese PLA General hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Study Officials

• Feng Duan, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qunfang Zhou, MD

CONTACT

86 19868000115; zhouqun988509@163.com

Feng Duan, MD

CONTACT

86 13910984586; duanfeng@vip.sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)