Combination of Radiation Therapy and Anti-PD-1 Antibody in Treating Patients With Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT03374293|
Recruitment Status : Recruiting
First Posted : December 15, 2017
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Radiation Drug: Anti-PD-1 Antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Radiation Therapy With Anti-PD-1 Antibody in Treating Patients With Unresectable Pancreatic Cancer|
|Actual Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Experimental Group
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.
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 .
Drug: Anti-PD-1 Antibody
Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes.
- Local control [ Time Frame: 2 year ]occurrence of local or regional progression
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: 3 months ]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
- Objective response rate [ Time Frame: 3 months ]Objective response rate as assessed by RECIST criteria
- Overall survival [ Time Frame: 2 year ]Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03374293
|Hangzhou Cancer Hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Shixiu Wu, MD +8657786826086 firstname.lastname@example.org|