| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreatic Cancer | Drug: Anti-PD-1 monoclonal antibody | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 830 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial |
| Actual Study Start Date : | April 1, 2019 |
| Estimated Primary Completion Date : | April 1, 2021 |
| Estimated Study Completion Date : | April 1, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
No Intervention: Chemotherapy group
Treatment with modified-FOLFIRINOX Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
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Experimental: Combination group
Treatment with modified-FOLFIRINOX and Anti-PD-1 antibody Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2, Anti-PD-1 antibody 3mg/kg
|
Drug: Anti-PD-1 monoclonal antibody
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Tingbo Liang, MD PhD | 8613666676128 | liangtingbo@zju.edu.cn |
| China, Zhejiang | |
| the First Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting |
| Hangzhou, Zhejiang, China, 310003 | |
| Contact: Liang TingBo, MD, PHD 086-571-87236688 liangtingbo@zju.edu.cn | |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 5, 2019 | ||||
| First Posted Date ICMJE | June 12, 2019 | ||||
| Last Update Posted Date | June 5, 2020 | ||||
| Actual Study Start Date ICMJE | April 1, 2019 | ||||
| Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: Through the study peirod, for 3 years ] The time of treatment until documented tumor progreesion.
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| Original Primary Outcome Measures ICMJE |
Progression-free survival [ Time Frame: Through the study peirod, for 2 years ] The time of treatment until documented tumor progreesion.
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| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination of Anti-PD-1 Antibody and Chemotherapy in Pancreatic Cancer | ||||
| Official Title ICMJE | Study on Therapeutic Effect of Combination of Anti-PD-1 Antibody and Chemotherapy in Locally Advanced or Borderline Resectable Pancreatic Cancer Patients: A Randomized Clinical Trial | ||||
| Brief Summary | The prognosis of pancreatic cancer is extremely poor. Current guidelines recommend FOLFIRINOX or modified-FOLFIRINOX as the first-line chemotherapeutic regimen. Studies have shown that immunotherapy with Anti-PD-1 antibody can effectively increase the response rate and prolong patient survival in a number of cancer diseases. Here investigators intend to compare the therapeutic effects of modified-FOLFIRINOX alone and the combination of modified-FOLFIRINOX and Anti-PD-1 antibody in patients with borderline resectable and locally advanced pancreatic cancer. | ||||
| Detailed Description | Investigators chose borderline resectable and locally advanced pancreatic cancer patients. The planned treatment was given to the participants after randomization. Response rate, recurrence-free survival, overall survival, drugs related side effects and other endpoints events were recorded and analyzed, to assess the combination treatment with modified-FOLFIRINOX and Anti-PD-1 antibody could or couldn't benefit the patients with borderline resectable and locally advanced pancreatic cancer. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Pancreatic Cancer | ||||
| Intervention ICMJE | Drug: Anti-PD-1 monoclonal antibody
Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
830 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | April 1, 2022 | ||||
| Estimated Primary Completion Date | April 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03983057 | ||||
| Other Study ID Numbers ICMJE | CISPD-4 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | TingBo Liang, Zhejiang University | ||||
| Study Sponsor ICMJE | Zhejiang University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Zhejiang University | ||||
| Verification Date | June 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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