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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03765190
Other study ID # 20181204
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, 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
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 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

Study Design


Related Conditions & MeSH terms


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
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