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New treatment option for Pancreatic Cancer
Official title PD-1 Combined With Chemotherapy and PULSAR in LAPC and Local Recurrence Patients
ClinicalTrials.gov ID: NCT06359275
What this study is testing
What is PD-1?
PD-1 is an investigational medicine, being studied as a potential treatment for pancreatic cancer.
Also referred to as immunotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is a phase II clinical trial of the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR radiotherapy in patients with locally advanced unresectable pancreatic cancer and patients with only local recurrence after pancreatic cancer surgery, to observe the safety and efficacy of PD-1 antibody (Toripalimab) in combination with paclitaxel (albumin-bound type) and gemcitabine and PULSAR in the treatment of patients with locally advanced unresectable pancreatic cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Sign the informed consent form. The subject has received a full explanation and understanding of the purpose, content, predicted how well it works...
- Target group
- Locally advanced pancreatic adenocarcinoma confirmed by histopathology or cytology, or pancreatic cancer with only local recurrence but no distant...
- There is at least one measurable objective lesion according to RECIST1.1 standards;
- ECOG score 0-1 points;
You likely can't join if
- Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past;
- Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time;
- Enroll in another clinical study at the same time, unless it is an observational (non-treatment) clinical study or an treatment clinical study...
- Have received radiotherapy for the upper abdomen in the past;
- Medical history and concurrent diseases
- Uncontrolled serious medical diseases that the researcher believes will affect the subject's ability to receive the treatment of the research plan...
See the full eligibility criteria
Who can join
- Sign the informed consent form. The subject has received a full explanation and understanding of the purpose, content, predicted how well it works, pharmacological effects, and risks of this trial, and the subject has...
- Target group
- Locally advanced pancreatic adenocarcinoma confirmed by histopathology or cytology, or pancreatic cancer with only local recurrence but no distant metastasis after surgery (local recurrence includes tumor bed recurrence...
- There is at least one measurable objective lesion according to RECIST1.1 standards;
- ECOG score 0-1 points;
- Expected survival time ≥ 3 months;
- Willing to comply with research procedures and able to undergo treatment (including surgery) and follow-up;
- There are no contraindications for the use of PD-1, PD-L1, gemcitabine and paclitaxel for injection (albumin-bound);
- There are no contraindications to radiotherapy;
- Abnormal physical examination and laboratory test results
- Hematological dysfunction is defined as i) absolute neutrophil (ANC) count ≥1.5×109/L; ii) platelet (PLT) count: ≥80×109/L; iii) hemoglobin (Hb) level ≥ 90g/L.
- Abnormal liver function is defined as: i) Total bilirubin (TBil) level: ≤ 1.5 times the upper limit of normal (ULN); ii) Aspartate aminotransferase (AST) and alanine; aminotransferase (ALT) levels ≤ 2.5 times the ULN...
- Abnormal renal function definition: serum creatinine ≤ 1.5 times ULN, or calculated creatinine clearance ≥ 50ml/min;
- Definition of abnormal coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN, unless the subject is...
- people who are positive for hepatitis B surface antigen (HBsAg) and whose peripheral blood hepatitis B virus deoxyribonucleic acid (HBV-DNA) titer is ≤1×103 copy number/L; if they are HBsAg-positive and whose peripheral...
- Age and reproductive status
- Men and women aged 18-75;
- people of childbearing age must agree to take adequate contraceptive measures during the trial; the serum or urine pregnancy test of women of childbearing age must be negative 24 hours before the start of chemotherapy;
- Women must be non-lactating.
What rules you out
- Have received anti-PD-1 or anti-PD-L1 antibody treatment in the past;
- Have received any investigational drugs within 4 weeks before using the investigational drugs for the first time;
- Enroll in another clinical study at the same time, unless it is an observational (non-treatment) clinical study or an treatment clinical study follow-up;
- Have received radiotherapy for the upper abdomen in the past;
- Medical history and concurrent diseases
- Uncontrolled serious medical diseases that the researcher believes will affect the subject's ability to receive the treatment of the research plan, such as combined with serious medical diseases, including severe heart...
- Have active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and need for bronchodilators...
- Have active tuberculosis infection. Patients with active pulmonary tuberculosis infection within 1 year before the medication will be excluded, even if they have been treated; patients with a history of active pulmonary...
- Previous interstitial lung disease or (non-infectious) pneumonia requiring oral or intravenous steroid therapy;
- Long-term systemic corticosteroids (dose equivalent to \>10 mg prednisone/day) or any other form of immunosuppressive treatment are required. people using inhaled or topical corticosteroids were eligible;
- Heart disease that is not well controlled, such as:
- New York Heart Association (NYHA) grade 2 or above heart failure
- Unstable angina pectoris
- Myocardial infarction occurred within 1 year
- Supraventricular or ventricular arrhythmias that are clinically significant and require treatment or intervention;
- Dementia, altered mental status, or any mental illness that would prevent understanding or giving informed consent or completing questionnaires;
- History of allergy or hypersensitivity reaction to any component of the treatment;
- Malignant tumors within 5 years, except for fully treated basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
- Previous systemic treatment for locally advanced pancreatic cancer;
- people who have been pathologically diagnosed with squamous cell carcinoma (not limited to organs) and received taxane-containing regimens as neoadjuvant/adjuvant treatment;
- people with ≥ grade 2 peripheral neuropathy according to CTCAE version 5.0.
- Hepatitis C virus (HCV) antibody positive or human immunodeficiency virus (HIV) antibody positive;
- Active infection requiring systemic treatment;
- Need to be combined with other anti-tumor drug treatments;
- Have received any experimental drug treatment or participated in another treatment clinical trial within 30 days of the screening period;
- The researcher believes that other circumstances are not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Shanhai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanhai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.