Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

Neoplasm Metastasis Clinical Trial

— PI-MMC  

Official title:

A Phase I/II Study of Combination of Proton Therapy With Immunotherapy in Multiple Metastases Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03765190
• Other study ID #: 20181204
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2019
• Est. completion date: December 1, 2022

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 proton radiation therapy in combination with immunotherapy(ie. Programmed cell death protein 1, also known as PD-1 antibody) in multiple metastases.

Description:

As is known to all, the main treatment method for metastatic tumors is systemic chemotherapy and radiotherapy is merely for the purpose of palliative treatment. Recent studies have shown that tumors with no more than 5 metastatic sites can still achieve satisfactory overall survival by local treatments such as radiotherapy. However, for tumors with more metastatic lesions, side effect is pretty high for photon radiotherapy due to the wide range of irradiation. Protons might be a safe treatment means for multiple metastases cancer because of the Brag peak, when the normal tissue dose can be significantly reduced. Combination of proton therapy with immunotherapy can be a research direction for multiple metastatic tumors. This study intends to observe the safety and efficacy of proton technique combined with immunotherapy in improving the overall anti- tumor effect for metastatic tumors.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed Unspecified Adult Solid Tumor

• Multiple metastatic tumors

• 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
• Neoplasm Metastasis
• Proton Therapy

Intervention

Combination Product:
• Radiation: Proton Therapy+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