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Pancreatic CancerPhase 1CISPD-2NCT03716596

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

A Phase 1 study testing SBRT and anti-PD-1 antibody in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
SBRT and anti-PD-1 antibody
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteChina
Study dates
22 Oct 2018to 22 Oct 2019
Phase
Phase 1
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

  • 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):
  • White blood cell (WBC) ≥3.5 x 10^6 /L, neutrophil >1.5 x10^9/L,
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  • platelet (PLT) ≥50 x10^9/L,
  • hemoglobin (HB) ≥80 g/L,
  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The second affiliated hospital of Zhejiang University

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

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

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.

Read the 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.

Being tested
SBRT, anti-PD-1 antibody
Keywords
pancreatic cancer, Second-line Chemotherapy resistant, immune therapy, Stereotactic Body Radiotherapy
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    Also called Stereotactic Body Radiotherapy

    SBRT radiation dose is 40-50 Gy in total.

  • anti-PD-1 antibodyDrug

    Also called keytruda

    Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.

Study groups in NCT03716596
Study groupRoleWhat they receive
SBRT and PD-1ExperimentalStereotactic body radiotherapy, radiation dose is 40-50 Gy in total. Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.
Receives: Radiation: SBRT; Drug: anti-PD-1 antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall survival

    The percentage of people still alive for a given period of time after diagnosis

    Measured: Up to approximately 12 months

Secondary outcomes (6)

  1. Disease control rate

    Percentage of patients whose cancer doesn't progress after treatment

    Measured: Up to approximately 12 months

  2. Objective response rate

    Percentage of patients whose cancer shrinks or disappears after treatment

    Measured: Up to approximately 12 months

  3. Progression-free survival

    The percentage of people does not get worse for a period of time after diagnosis

    Measured: Up to approximately 12 months

  4. EORTC quality of life questionnaire (QLQ)

    Assessed by the European Organization for Research and Treatment of Cancer Quality of Life

    Measured: Up to approximately 12 months

  5. Common Toxicity Criteria for Adverse Effects

    According to Common Toxicity Criteria for Adverse Effects version 4

    Measured: Up to approximately 12 months

  6. Related tumor markers

    Serum level of related tumor markers (like carbohydrate antigen19-9, carcinoembryonic antigen and so on)

    Measured: Up to approximately 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2018
  2. Study start22 Oct 2018
  3. Primary completion22 Oct 2019
  4. Study completion22 Oct 2019

Why it stopped: The effect of the regime was not satisfied

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03716596
Sponsor's protocol ID
CISPD-2
Acronym
CISPD-2
Status last verified
Oct 2018
First submitted
21 Oct 2018
Last updated
20 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBRT and anti-PD-1 antibody in people with Pancreatic Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 11 inclusion and 20 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: stopped early, as of the sponsor's last update on 20 Sep 2024. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The effect of the regime was not satisfied). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall survival (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03716596.

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 20 Sep 2024.

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