Combination of Hypofractionated Proton Therapy With Immun... | NCT03764787

Studies
Combination of Hypofractionated Proton Therapy With Immunotherapy

NCT03764787

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Dec 5, 2018Actual

Enrollment

30Estimated

Phase

Phase 1Phase 2

Conditions

Proton Therapy
Immunotherapy

Interventions

Radiation+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, 2021Estimated

Completion Date

Dec 1, 2021Estimated

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 hypofractionated proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody). Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.

Detailed Description

Hypofractionated radiotherapy (HFRT), also known as Stereotactic body radiation therapy (SBRT) or Stereotactic ablative radiotherapy (SABR), is a regular pattern of photon radiotherapy. HFRT could achieve comparable curative effect to surgery in variable type of tumor. With the development of proton radiotherapy technology, proton HFRT technique is available nowadays. However, proton HFRT technique is mainly effective in improving the local control rates. This study intends to observe the safety and efficacy of proton HFRT technique combined with immunotherapy in improving the overall anti-tumor effect.

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+PD-1 Ab	Experimental	proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)	Combination Product: Radiation+PD-1 Ab

Interventions

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