Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-01

Brief Summary

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The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody) in multiple metastases.

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Detailed Description

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As is known to all, the main treatment method for metastatic tumors is systemic chemotherapy and radiotherapy is merely for the purpose of palliative treatment. Recent studies have shown that tumors with no more than 5 metastatic sites can still achieve satisfactory overall survival by local treatments such as radiotherapy. However, for tumors with more metastatic lesions, side effect is pretty high for photon radiotherapy due to the wide range of irradiation. Protons might be a safe treatment means for multiple metastases cancer because of the Brag peak, when the normal tissue dose can be significantly reduced. Combination of proton therapy with immunotherapy can be a research direction for multiple metastatic tumors. This study intends to observe the safety and efficacy of proton technique combined with immunotherapy in improving the overall anti- tumor effect for metastatic tumors.

Conditions

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Proton Therapy Immunotherapy Neoplasm Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Proton Therapy+PD-1 Ab

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiation: Proton Therapy+PD-1 Ab

proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)

Group Type EXPERIMENTAL

Radiation: Proton Therapy+PD-1 Ab

Intervention Type COMBINATION_PRODUCT

combination of proton radiotherapy with PD-1 antibody

Interventions

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Radiation: Proton Therapy+PD-1 Ab

combination of proton radiotherapy with PD-1 antibody

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* Pathologically confirmed Unspecified Adult Solid Tumor
* Multiple metastatic tumors
* Intending to be treated with proton beam and immunotherapy
* Age ≥ 18 years old
* KPS≥70
* Signed written informed consent.

Exclusion Criteria

* Pregnant or breastfeeding woman
* Patient under guardianship or tutorship
* Patients or legal guardians who are unable to understand informed consent document

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No