Proton TherapyPhase 1/2I-HypoPTNCT03764787
Combination of Hypofractionated Proton Therapy With Immunotherapy
A Phase 1/2 study testing Radiation+PD-1 Ab in people with Proton Therapy and Immunotherapy, run by Peking University First Hospital.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Therapy, Immunotherapy
- What is being tested?
- Radiation+PD-1 Ab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or breastfeeding woman
- Patient under guardianship or tutorship
- Patients or legal guardians who are unable to understand informed consent document
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
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.
Read the 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
- Being tested
- Radiation+PD-1 Ab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation+PD-1 AbCombination product
combination of proton radiotherapy with PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Radiation+PD-1 Ab | Experimental | proton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year) Receives: Combination Product: Radiation+PD-1 Ab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Assess adverse events according to CTCAE4.0
Measured: Through 1 years after completion of treatment
Secondary outcomes (2)
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.
Measured: Through 2 years after completion of treatment
Overall survival (OS)
OS is defined as the duration of time from start of treatment to time of death.
Measured: Through 2 years after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton TherapyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- YiZhou International Cancer Hospital
- Responsible party
- Principal investigator, Xian-shu Gao, Peking University First Hospital
- Investigators
- Xianshu Gao, MD,PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764787
- Sponsor's protocol ID
- 20181203
- Acronym
- I-HypoPT
- Status last verified
- Dec 2018
- First submitted
- 3 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Combination of Hypofractionated Proton Therapy With Immunotherapy
- ClinicalTrials.gov ID
- NCT03764787
- Acronym / sponsor ID
- I-HypoPT / 20181203
- Conditions
- Proton Therapy, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- YiZhou International Cancer Hospital
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation+PD-1 Ab | Experimental | Combination Product: Radiation+PD-1 Abproton radiotherapy concurrent with immunotherapy(ie. PD-1 Ab for 1 year) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding woman
- Patient under guardianship or tutorship
- Patients or legal guardians who are unable to understand informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation+PD-1 Abcombination of proton radiotherapy with PD-1 antibody | Combination product | Radiation+PD-1 Ab |
Primary outcome
Adverse events
Time frame: Through 1 years after completion of treatment
Assess adverse events according to CTCAE4.0
2 secondary outcomes
Progression-free survival (PFS)
Time frame: Through 2 years after completion of treatment
Overall survival (OS)
Time frame: Through 2 years after completion of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianshu Gao, MD,PhD principal investigator
Peking University First Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Radiation+PD-1 Ab in people with Proton Therapy and Immunotherapy, run by Peking University First Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Bai, MD ((+86)010 83575641, 08043@pkufh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Through 1 years after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.