Combination of Proton Therapy With Immunotherapy in Multi... | NCT03765190

Studies
Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

NCT03765190

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Dec 5, 2018Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Proton Therapy
Immunotherapy
Neoplasm Metastasis

Interventions

Radiation: Proton Therapy+PD-1 Ab

Countries

Not provided

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Estimated

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Dec 1, 2022Estimated

First Submitted Date

Dec 3, 2018

First Submission Date that Met QC Criteria

Dec 3, 2018

First Posted Date

Dec 5, 2018Actual

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

Dec 3, 2018

Last Update Posted Date

Dec 5, 2018Actual

Name	Class
YiZhou International Cancer Hospital	UNKNOWN

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

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.

Detailed Description

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.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiation: Proton Therapy+PD-1 Ab	Experimental	proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)	Combination Product: Radiation: Proton Therapy+PD-1 Ab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiation: Proton Therapy+PD-1 Ab	Combination Product	combination of proton radiotherapy with PD-1 antibody	Radiation: Proton Therapy+PD-1 Ab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Assess adverse events according to CTCAE4.0	Through 1 years after completion of treatment

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival (PFS)	PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.	Through 2 years after completion of treatment
Overall survival (OS)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yun Bai, MD	Contact	(+86)010 83575641		08043@pkufh.com

Overall Officials

Name	Affiliation	Role
Xianshu Gao, MD,PhD	Peking University First Hospital	Principal Investigator

Locations

Not provided

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

Condition Browse Module

MeSH Terms

ID	Term
D009362	Neoplasm Metastasis

Ancestor Terms

ID	Term
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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