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

NCT03716596 | Terminated Phase 1 DMC

• 1 other identifier: CISPD-2
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; Second-line Chemotherapy resistant; immune therapy; Stereotactic Body Radiotherapy

Outcome Measures

Primary Outcomes (1)

• overall survival

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

  Up to approximately 12 months

Secondary Outcomes (6)

• Disease control rate

  Up to approximately 12 months

• Objective response rate

  Up to approximately 12 months

• Progression-free survival

  Up to approximately 12 months

• EORTC quality of life questionnaire (QLQ)

  Up to approximately 12 months

• Common Toxicity Criteria for Adverse Effects

  Up to approximately 12 months

Study Arms (1)

SBRT and PD-1

EXPERIMENTAL

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; Drug: anti-PD-1 antibody

Interventions

SBRT RADIATION

SBRT radiation dose is 40-50 Gy in total.

Also known as: Stereotactic Body Radiotherapy

SBRT and PD-1

anti-PD-1 antibody DRUG

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

Also known as: keytruda

SBRT and PD-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years.
• Histopathology or cytology confirmed pancreatic cancer.
• 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).
• \. Eastern cooperative oncology group physical fitness score was 0\~2.
• \. 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,
• 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).
• \) Serum creatinine (Scr) ≤ 1.5 x ULN 7) Albumin (ALB) ≥ 3 g/dL.
• \. Patients will be informed consent, and understand and are willing to cooperate with the trial and sign related documents.

You may not qualify if:

• \. In the first 4 weeks before the start of the study, they took part in other drug clinical trials.
• \. Before the start of the study, they were diagnosed as immune deficiency diseases or need systemic steroid therapy.
• \. 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.
• \. 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.
• \. Has had active tuberculosis before.
• \. Has a history of malignant tumor, except for basal and skin squamous cell carcinoma, cervical carcinoma in situ and papillary thyroid carcinoma.
• \. Has central nervous system metastasis or meningeal metastasis.
• \. 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.
• \. Has blood precancerous diseases, such as myelodysplastic syndrome.
• \. 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.
• \. 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).
• \. Has preexisting neuropathy at \> level 1 (NCI CTCAE).
• \. Allotransplantation requires immunosuppression therapy or other major immunosuppression therapy.
• \. Has a severe open wound, ulcer, or fracture.
• \. Systemic treatment is required for autoimmune diseases that have been active for the past 2 years.Alternative therapies are not systemic treatments.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiosurgery; spartalizumab; pembrolizumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tingbo Liang, MD PhD

  second affiliated hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 23, 2018
• Study Start: October 22, 2018
• Primary Completion: October 22, 2019
• Study Completion: October 22, 2019
• Last Updated: September 20, 2024

Record last verified: 2018-10

Locations

CN (1)