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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03764787
Other study ID # 20181203
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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