Combination of Hypofractionated Proton Therapy With Immunotherapy

NCT ID: NCT03764787

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-01

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.

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.

Conditions

Proton Therapy; Immunotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation+PD-1 Ab

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

Group Type: EXPERIMENTAL

Radiation+PD-1 Ab

Intervention Type: COMBINATION_PRODUCT

combination of proton radiotherapy with PD-1 antibody

Interventions

Radiation+PD-1 Ab

combination of proton radiotherapy with PD-1 antibody

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

YiZhou International Cancer Hospital

UNKNOWN

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xian-shu Gao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xianshu Gao, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Central Contacts

Yun Bai, MD

Role: CONTACT

08043@pkufh.com

(+86)010 83575641

Other Identifiers

20181203

Identifier Type: -

Identifier Source: org_study_id