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Tests treatment safety and results for Unresectable Pancreatic Cancer
Official title Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC) and Advanced Pancreatic Cancer With Lymph Node Metastases
ClinicalTrials.gov ID: NCT06278454
What this study is testing
What is NRT6008 Injection + Systematic chemotherapy?
NRT6008 Injection + Systematic chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for unresectable pancreatic cancer.
Also referred to as Investigational Product + Systematic chemotherapy.
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 is a single arm, open label, multi-center phase I study, including phase Ia dose escalation and phase Ib dose expansion. Safety review committee (SRC) will be formed to monitor safety and efficacy data through the study.
- Phase 1: an early, usually small safety study
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 80
You may be able to join if
- Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
- Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
- Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having...
- ECOG performance status score ≤1;
- Expected survival ≥3 months;
You likely can't join if
- Allergic to the investigational drug NRT6008 injection itself or any of its components;
- Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
- Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc...
- Contraindications to anesthesia;
- History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin...
- Presence or suspected presence of distant metastases according to imaging;
See the full eligibility criteria
- Aged ≥18 years and ≤80 years, able to comprehend and sign an informed consent form;
- Diagnosed with pancreatic adenocarcinoma confirmed histologically or cytologically;
- Evaluated as unresectable LAPC or metastatic pancreatic cancer with lymph node metastasis only, as determined by the investigator; or having contraindications to surgery, or refusing surgical resection;
- ECOG performance status score ≤1;
- Expected survival ≥3 months;
- According to RECIST v1.1 criteria, there is only one measurable lesion in the pancreas confirmed by imaging, and the lesion has the shortest axis diameter ≥2.0 cm, the longest axis diameter ≤6.0 cm (based on baseline...
- Adequate normal organ and marrow function as defined below: (1) Renal function: serum creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL/min (calculated by the Cockcroft-Gault formula); (2) Liver function: aspartate...
- Female and male participants of reproductive age must voluntarily agree to practice strict and effective contraception after signing the informed consent form, during the study period, and within 12 months after...
- Allergic to the investigational drug NRT6008 injection itself or any of its components;
- Contraindications to any of the three optional systemic chemotherapy regimens in this study judged by investigators;
- Previous anti-tumor treatments for pancreatic cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. Except for discontinuation of traditional chinese medicine or herbal...
- Contraindications to anesthesia;
- History of any other malignant tumors within 5 years before receiving investigational drug treatment, except for cases of cured non-melanoma skin cancer, cervical carcinoma in situ, or basal cell carcinoma of the skin...
- Presence or suspected presence of distant metastases according to imaging;
- Pregnant or lactating females;
- Participants assessed by the investigators to be at high risk or had difficulty in operation for EUS-FNI procedures;
- Evidence of radiographic invasion into stomach, duodenum or peritoneum;
- Participants with chronic diseases that are actively treated but not well controlled, such as primary hypertension, diabetes, etc.;
- Within 6 months prior to the the first administration of chemotherapy, occurrence of acute pancreatitis, severe gastrointestinal bleeding, severe cardiovascular diseases (including but not limited to stroke, unstable...
- Participated in other treatment clinical trials within 1 month prior to the first administration of chemotherapy;
- Positive for human immunodeficiency virus (HIV) antibodies;
- Positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), HBV DNA testing required, participants with HBV-DNA levels below the lower limit of the reference range or \< 500...
- Positive for hepatitis C virus (HCV) antibodies, HCV RNA testing required, participants with negative HCV RNA results will be eligible for inclusion in this study;
- Participants with syphilis infection or active tuberculosis;
- Other reasons deemed unsuitable for participation in this trial by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Suzhou, Jiangsu, China
- Shanghai, Shanghai Municipality, China
- Chongqing, China
- Tianjin, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Suzhou, Jiangsu, China; Shanghai, Shanghai Municipality, China; Chongqing, China; Tianjin, 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.