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SBRT and Anti-programmed Cell Death Protein 1(Anti-PD-1) in Late Stage or Recurrent Pancreatic Cancer Patients (CISPD-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716596
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
When gemcitabine based chemo and fluorouracil based chemo regimes are failed in late-stage or recurrent pancreatic cancer patients, there is no alternative options. Anti-PD-1 antibody has became a promising anti-cancer drug. While it showed limited efficacy in pancreatic cancer. Stereotactic Body Radiotherapy has been a new method to locally treat metastatic cancer. This study is aimed to evaluate the safety and efficacy of the combination of SBRT and anti-PD-1 antibody in late-stage or recurrent pancreatic caner who failed in second-line chemotherapy.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: SBRT Drug: anti-PD-1 antibody Phase 1

Detailed Description:
Pancreatic cancer is a kind of cancer with poor prognosis. Nowadays, recommended treatment for late-stage or recurrent pancreatic cancer patients are fluorouracil based chemotherapy (such as FOLFIRINOX) and gemcitabine based chemotherapy. When these two chemo regimes are failed, however, there is no alternative options. With the improvement of immune therapy, anti-PD-1 antibody has became a promising anti-cancer drug. While it showed limited efficacy in pancreatic cancer. Stereotactic Body Radiotherapy (SBRT) has been a new method to locally treat metastatic cancer. And previous studies showed that SBRT may enhance the efficacy of immunotherapy. So this study is amed to evaluate the safety and efficacy of the combination of SBRT and anti-PD-1 antibody in late-stage or recurrent pancreatic caner who failed in second-line chemotherapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study on the Safety and Therapeutic Effect of Stereotactic Body Radiotherapy and Anti-PD-1 Antibody in Late Stage or Recurrent Pancreatic Cancer Patients Who Failed in Second-line Chemotherapy
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : October 22, 2021
Estimated Study Completion Date : October 22, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SBRT and PD-1
Stereotactic body radiotherapy, radiation dose is 40-50 Gy in total. Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.
Radiation: SBRT
SBRT radiation dose is 40-50 Gy in total.
Other Name: Stereotactic Body Radiotherapy

Drug: anti-PD-1 antibody
Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.
Other Name: keytruda




Primary Outcome Measures :
  1. overall survival [ Time Frame: Up to approximately 12 months ]
    The percentage of people still alive for a given period of time after diagnosis


Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: Up to approximately 12 months ]
    Percentage of patients whose cancer doesn't progress after treatment

  2. Objective response rate [ Time Frame: Up to approximately 12 months ]
    Percentage of patients whose cancer shrinks or disappears after treatment

  3. Progression-free survival [ Time Frame: Up to approximately 12 months ]
    The percentage of people does not get worse for a period of time after diagnosis

  4. EORTC quality of life questionnaire (QLQ) [ Time Frame: Up to approximately 12 months ]
    Assessed by the European Organization for Research and Treatment of Cancer Quality of Life

  5. Common Toxicity Criteria for Adverse Effects [ Time Frame: Up to approximately 12 months ]
    According to Common Toxicity Criteria for Adverse Effects version 4

  6. Related tumor markers [ Time Frame: Up to approximately 12 months ]
    Serum level of related tumor markers (like carbohydrate antigen19-9, carcinoembryonic antigen and so on)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.≥18 years.
  • 2.Histopathology or cytology confirmed pancreatic cancer.
  • 3.Patients failed in second-line chemotherapy: patients have failed in gemcitabine-based chemotherapy and also failed in fluorouracil-based chemotherapy (like FOLFIRINOX), failed in combination of chemotherapy and radiotherapy; patients may have failed in immune therapy (including anti-PD-1 antibody).
  • 4. Eastern cooperative oncology group physical fitness score was 0~2.
  • 5. The main organs are functional and meet the following criteria (Routine blood tests were in accordance with the following criteria):

    1. White blood cell (WBC) ≥3.5 x 10^6 /L, neutrophil >1.5 x10^9/L,
    2. platelet (PLT) ≥50 x10^9/L,
    3. hemoglobin (HB) ≥80 g/L,
    4. total bilirubin (TB) ≤1.5 x ULN (upper limit of normal value). 5)Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2 x ULN (upper limit of normal value) (if there is liver metastasis, ≤ 5 x ULN).

    6) Serum creatinine (Scr) ≤ 1.5 x ULN 7) Albumin (ALB) ≥ 3 g/dL.

  • 6. Patients will be informed consent, and understand and are willing to cooperate with the trial and sign related documents.

Exclusion Criteria:

  • 1. In the first 4 weeks before the start of the study, they took part in other drug clinical trials.
  • 2. Before the start of the study, they were diagnosed as immune deficiency diseases or need systemic steroid therapy.
  • 3. In the first 4 weeks before the start of the study, they took anti-tumor immune therapy; or didn't recovery from the adverse effects caused by the anti-tumor immune therapy.
  • 4. In the first 2 weeks before the start of the study, they took chemotherapy, small molecule targeting therapy, and radiotherapy; or didn't recovery from the adverse effects caused by these therapies.
  • 5. Has had active tuberculosis before.
  • 6. Has a history of malignant tumor, except for basal and skin squamous cell carcinoma, cervical carcinoma in situ and papillary thyroid carcinoma.
  • 7. Has central nervous system metastasis or meningeal metastasis.
  • 8. Has serious and uncontrollable internal diseases such as severe diabetes, severe hypertension, serious infection, congestive heart failure, ventricular fibrillation, coronary heart disease with obvious symptoms or myocardial infarction in the past 6 months.
  • 9. Has blood precancerous diseases, such as myelodysplastic syndrome.
  • 10. Has clinically relevant or preexisting interstitial lung diseases, such as noncommunicable pneumonia or pulmonary fibrosis, or evidence of interstitial lung diseases on baseline chest CT scans or chest x-rays.
  • 11. Past or physical examinations have found diseases of the central nervous system, with the exception of those that have been adequately treated (such as primary brain tumors, uncontrolled seizures or strokes with standard medication).
  • 12. Has preexisting neuropathy at > level 1 (NCI CTCAE).
  • 13. Allotransplantation requires immunosuppression therapy or other major immunosuppression therapy.
  • 14. Has a severe open wound, ulcer, or fracture.
  • 15. Systemic treatment is required for autoimmune diseases that have been active for the past 2 years.Alternative therapies are not systemic treatments.
  • 16. Has a history of non-infectious pneumonia requiring steroid therapy or active pneumonia.Has interstitial lung disease.
  • 17. Patients with active infections require systemic treatment.
  • 18. Patients with active hepatitis b or c are not included in liver lesions SBRT.
  • 19. Has vaccinate within 30 days before treatment.Including intranasal influenza vaccines, except seasonal influenza vaccines
  • 20. Others: allergic history of similar drugs, pregnancy or lactation.

Information from the National Library of Medicine

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): NCT03716596


Contacts
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Contact: Yiwen Chen, MD +8615088682641 cherry0705@zju.edu.cn
Contact: Qi Zhang, MD +8613858108798 zhangqi86@gmail.com

Locations
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China, Zhejiang
The second affiliated hospital of Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Yiwen Chen, MD    +8615088682641    cherry0705@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Tingbo Liang, MD PhD second affiliated hospital, Zhejiang University School of Medicine

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03716596    
Other Study ID Numbers: CISPD-2
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
pancreatic cancer
Second-line Chemotherapy resistant
immune therapy
Stereotactic Body Radiotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs