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Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

NCT ID: NCT05584267

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-25

Study Completion Date

2026-12-31

Brief Summary

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This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.

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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cohort A

Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy

Group Type ACTIVE_COMPARATOR

Chemotherapy + immunotherapy

Intervention Type DRUG

Chemotherapy + immunotherapy

cohort B

Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

Different cohorts received different doses of radiotherapy

Chemotherapy + immunotherapy

Intervention Type DRUG

Chemotherapy + immunotherapy

cohort C

Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

Different cohorts received different doses of radiotherapy

Chemotherapy + immunotherapy

Intervention Type DRUG

Chemotherapy + immunotherapy

Interventions

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radiotherapy

Different cohorts received different doses of radiotherapy

Intervention Type RADIATION

Chemotherapy + immunotherapy

Chemotherapy + immunotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years of age on day of signing informed consent
* Histopathology confirmed non-small cell lung cancer
* Asymptomatic brain metastases
* EGFR/ALK ROS1 driver gene mutation negative
* RECIST 1.1 based available assessment of lesions
* ECOG 0-1
* Brain metastases 1-4
* Single lesion ≤4cm

Exclusion Criteria

* Patients with contraindication of chemotherapy Pregnant or breast feeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hunan Province Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yongchang Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hunan Cancer Hospital

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongchang C Zhang, MD

Role: CONTACT

[email protected]
+8613873123436 ext. 7+861383123436

Nong C Yang, MD

Role: CONTACT

[email protected]
+8613873123436 ext. +8613873123436

Facility Contacts

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Yongchang Zhang, MD

Role: primary

[email protected]
+86 731 89762323

Nong Yang, MD

Role: backup

[email protected]
+86 731 89762321

Other Identifiers

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RENO

Identifier Type: -

Identifier Source: org_study_id

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