Antirotinib Hydrochloride Plus Whole Brain Radiotherapy f... | NCT06611657

Studies
Antirotinib Hydrochloride Plus Whole Brain Radiotherapy for Small Cell Lung Cancer With Brain Metastases

NCT06611657

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Status

Active, not recruiting

Last Update Posted

Oct 16, 2024Actual

Enrollment

40Actual

Phase

Phase 2

Conditions

Whole Brain Radiotherapy

Interventions

Antirotinib hydrochloride

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2021Actual

Primary Completion Date

Jun 10, 2024Actual

Completion Date

Jul 30, 2025Estimated

First Submitted Date

Sep 22, 2024

First Submission Date that Met QC Criteria

Sep 22, 2024

First Posted Date

Sep 25, 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

Oct 14, 2024

Last Update Posted Date

Oct 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The objective of this study was to evaluate the efficacy and safety of whole brain radiotherapy combined with antirotinib hydrochloride in the treatment of brain metastases in small cell lung cancer

Detailed Description

This was a single-center, single-arm trail. Enrolled patients were pathologically diagnosed with small cell lung cancer and had completed at least 4 cycles of first-line chemotherapy. Patients with brain metastases at first visit or during treatment were treated with whole brain radiotherapy combined with anlotinib hydrochloride. Oral antirotinib was started 2 weeks before radiotherapy for brain metastases and stopped for 1 week after 2 weeks. After radiotherapy, antirotinib was continued until tumor progression. Efficacy and toxicity data were collected for evaluation and analysis.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anlotinib hydrochloride	Experimental	Subjects received antirotinib hydrochloride capsules, 1 capsule (12mg) once a day.	Drug: Antirotinib hydrochloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antirotinib hydrochloride	Drug	Oral antirotinib treatment was started 2 weeks before radiotherapy for brain metastases, stopped for 1 week after 2 weeks, and continued after radiotherapy until tumor progression

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intracranial progression-free survival	Time from enrollment to intracranial tumor progression or death	6 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	The time from enrollment to death from any cause was calculated as the time of death. For participants who were lost to follow-up, the time of death was usually the time of the last follow-up.	1 year
progression-free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Small cell lung cancer confirmed by pathology, completion of at least 4 cycles of first-line chemotherapy, and measurable disease according to RECIST criteria.
The expected survival time is more than 3 months.
Intracranial metastases ≤10.
Adequate organ and bone marrow function.

Exclusion Criteria:

Patients who have used antiangiogenic drugs within the previous 1 month.
Non-small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer).
Small cell lung cancer with hilar invasion or hemoptysis.
Patients with intracranial acute, subacute cerebral infarction, intracranial lesions acute, subacute hemorrhage.
An unresolved acute toxic reaction period higher than grade 2 of CTC-AE(4.0) due to any prior treatment.
Advanced patients with severe symptoms, tumors that have spread to the internal organs, and a short-term risk of life-threatening complications.
Patients with life-threatening conditions of other severe and/or uncontrolled diseases.

Accepts Healthy Volunteers

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

Not provided

Overall Officials

Name	Affiliation	Role
Lei Deng, MD	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Hospital Chinese Academy of Medical Sciences		Beijing	Beijing Municipality	100021	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided