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

Peking University

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Immunotherapy

Proton Therapy

Treatments

Combination Product: Radiation+PD-1 Ab

Study type

Interventional

Funder types

Other

Identifiers

NCT03764787

20181203

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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