Combination of Hypofractionated Proton Therapy With Immunotherapy

Immunotherapy Clinical Trial

— I-HypoPT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03764787
• Other study ID #: 20181203
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2018
• Source: Peking University First Hospital
• Contact: Yun Bai, MD
• Phone: (+86)010 83575641
• Email: 08043[@]pkufh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunotherapy
• Proton Therapy

Intervention

Combination Product:
• Radiation+PD-1 Ab
combination of proton radiotherapy with PD-1 antibody

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University First Hospital	YiZhou International Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Assess adverse events according to CTCAE4.0	Through 1 years after completion of treatment
Secondary	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
Secondary	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