I-HypoPT: Combination of Hypofractionated Proton Therapy With Immunotherapy

Sponsor

Peking University First Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03764787

Collaborator

YiZhou International Cancer Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proton Therapy Immunotherapy	Combination Product: Radiation+PD-1 Ab	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radiation+PD-1 Ab proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year)	Combination Product: Radiation+PD-1 Ab combination of proton radiotherapy with PD-1 antibody

Arm

Intervention/Treatment

Experimental: Radiation+PD-1 Ab

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

Combination Product: Radiation+PD-1 Ab

combination of proton radiotherapy with PD-1 antibody

Outcome Measures

Primary Outcome Measures

Adverse events [Through 1 years after completion of treatment]
Assess adverse events according to CTCAE4.0

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University First Hospital
YiZhou International Cancer Hospital

Investigators

Principal Investigator: Xianshu Gao, MD,PhD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xian-shu Gao, Professor, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT03764787

Other Study ID Numbers:

20181203

First Posted:

Dec 5, 2018

Last Update Posted:

Dec 5, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 5, 2018