Pancreatic CancerPhase 2NCT03374293
Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer
A Phase 2 study testing Radiation and Anti-PD-1 Antibody in people with Pancreatic Cancer, run by Shixiu Wu at 1 site in China.
Trial summary
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody in patients with pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Radiation and Anti-PD-1 Antibody
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Dec 2021
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age:18-75 years, male or female.
- Histologically or cytologically confirmed pancreatic cancer.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
- Life expectancy of greater than 12 weeks.
- Adequate organ function.
- Patient has given written informed consent.
Who cannot join
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
- Active infection or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
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- History of Interstitial Pneumonia or active non-infectious pneumonitis.
- Known Human Immunodeficiency Virus (HIV) infection、active Hepatitis B or Hepatitis C.
- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) agent.
- Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy.
- Has received prior anti-cancer monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study Day 1 or not recovered from adverse events due to a previously administered agent.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Pregnancy or breast feeding. Decision of unsuitableness by principal investigator or physician-in-charge.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000
Shixiu Wu, MD, +8657786826086, wushixiu@medmail.com.cn
About this study
Official title: Phase II Study of Radiation Therapy With Anti-PD-1 Antibody in Treating Patients With Unresectable Pancreatic Cancer
The objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody in patients with pancreatic cancer
- Conditions
- Pancreatic Cancer
- Being tested
- Radiation, Anti-PD-1 Antibody
- Keywords
- pancreatic cancer, Radiation, Anti-PD-1 Antibody
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiationRadiation
RT to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody .
Anti-PD-1 AntibodyDrug
Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Radiation to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes. Receives: Radiation: Radiation; Drug: Anti-PD-1 Antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control
occurrence of local or regional progression
Measured: 2 year
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by Number of participants with treatment-related adverse events as assessed by treatment-related adverse events assessed by CTCAE v4.0
Measured: 3 months
Objective response rate
Objective response rate as assessed by RECIST criteria
Measured: 3 months
Overall survival
Overall survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start1 Dec 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shixiu Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shixiu Wu, Hangzhou Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03374293
- Sponsor's protocol ID
- HangzhouCH10
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Radiation Therapy With Anti-PD-1 Antibody in Treating Patients With Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT03374293
- Acronym / sponsor ID
- HangzhouCH10
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, Radiation, Anti-PD-1 Antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shixiu WuUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Dec 2017 (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 objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-PD-1 antibody in patients with pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Radiation: Radiation, Drug: Anti-PD-1 AntibodyRadiation to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age:18-75 years, male or female.
- Histologically or cytologically confirmed pancreatic cancer.
- Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Can provide either a newly obtained or archival tumor tissue sample.
- ECOG 0-1.
Key exclusion criteria (13 listed)
- Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
- Other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers.
- Known central nervous system (CNS) metastases.
- Subjects with any active autoimmune disease or history of autoimmune disease.
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) > NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
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 |
|---|---|---|
| RadiationRT to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody . | Radiation | Experimental Group |
| Anti-PD-1 AntibodyAnti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes. | Drug | Experimental Group |
Primary outcome
Local control
Time frame: 2 year
occurrence of local or regional progression
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 3 months
Objective response rate
Time frame: 3 months
Overall survival
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiation and Anti-PD-1 Antibody in people with Pancreatic Cancer, run by Shixiu Wu at 1 site in China.
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 8 inclusion and 13 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control (time frame: 2 year). 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 10 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.