Combination of Hypofractionated Proton Therapy With Immunotherapy

NCT03764787 | Unknown Phase 1

• 1 other identifier: 20181203
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Proton Therapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Assess adverse events according to CTCAE4.0

  Through 1 years after completion of treatment

Secondary Outcomes (2)

• Progression-free survival (PFS)

  Through 2 years after completion of treatment

• Overall survival (OS)

  Through 2 years after completion of treatment

Study Arms (1)

Radiation+PD-1 Ab

EXPERIMENTAL

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

Combination Product: Radiation+PD-1 Ab

Interventions

Radiation+PD-1 Ab COMBINATION_PRODUCT

combination of proton radiotherapy with PD-1 antibody

Radiation+PD-1 Ab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University First Hospital: lead
• YiZhou International Cancer Hospital: collaborator

Study Officials

• Xianshu Gao, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun Bai, MD

CONTACT

(+86)010 83575641; 08043@pkufh.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 5, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share