BAI-BACE for Advanced Lung Squamous Cell Carcinoma

August 8, 2024 updated by: Zhou Qunfang, Sun Yat-sen University

Bronchial Arterial Infusion Plus Bronchial Arterial Chemoembolization (BAI-BACE) for Advanced Lung Squamous Cell Carcinoma: a Multicenter Single-arm Phase II Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BAI-BACE
Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI)
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 the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free-Survival (PFS)
Time Frame: 12 months
Progression was defined as progressive disease by independent radiologic review
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 24 months
OS is the length of time from the date of inclusion until death from any cause.
24 months
Objective response rate (ORR)
Time Frame: 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.
12 months
Adverse events
Time Frame: 24 months
Safety will be evaluated according to the NCI CTCAE Version 4.03. All observations
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Feng duan, MD, Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEST-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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