BAI-BACE for Advanced Lung Squamous Cell Carcinoma | NCT06377735

Studies
BAI-BACE for Advanced Lung Squamous Cell Carcinoma

NCT06377735

Sponsor

Sun Yat-sen University

Status

Recruiting

Last Update Posted

Aug 9, 2024Actual

Enrollment

85Estimated

Phase

Not Applicable

Conditions

Squamous Cell Carcinoma

Interventions

BAI-BACE

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Apr 17, 2024

First Submission Date that Met QC Criteria

Apr 17, 2024

First Posted Date

Apr 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2024

Last Update Posted Date

Aug 9, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

85Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BAI-BACE	Experimental	Bronchial arterial infusion, bronchial arterial chemoembolization (BACE-BAI)	Procedure: BAI-BACE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Overall survival (OS)	OS is the length of time from the date of inclusion until death from any cause.	24 months
Objective response rate (ORR)	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
Images within 2 weeks before inclusion;
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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qunfang Zhou, MD	Contact	86 19868000115		zhouqun988509@163.com
Feng Duan, MD	Contact	86 13910984586		duanfeng@vip.sina.com

Overall Officials

Name	Affiliation	Role
Feng Duan, MD	Chinese PLA General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chinese PLA General hospital	Recruiting	Beijing	Beijing Municipality	100853	China

Condition Browse Module

MeSH Terms

ID	Term
D002294	Carcinoma, Squamous Cell

Ancestor Terms

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

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.