Combination of Hypofractionated Proton Therapy With Immunotherapy (I-HypoPT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Immunotherapy; Proton Therapy
• Intervention / Treatment: Combination product: Radiation+PD-1 Ab

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	OS is defined as the duration of time from start of treatment to time of death.	Through 2 years after completion of treatment

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: YiZhou International Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 5, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 20181203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No