Actively Recruiting
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)
Led by Chengdu New Radiomedicine Technology Co. LTD. · Updated on 2025-03-24
58
Participants Needed
6
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. And the independent review committee (IRC) will be formed to monitor efficacy data through the study.
CONDITIONS
Official Title
Safety and Efficacy of NRT6008 in Patients With Unresectable Locally Advanced Pancreatic Cancer (LAPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years and able to understand and sign informed consent
- Diagnosed with pancreatic adenocarcinoma confirmed by tissue or cell analysis
- Evaluated as unresectable locally advanced pancreatic cancer or unsuitable for surgery or refusing surgery (only patients without non-regional lymph node metastasis are eligible)
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- One measurable pancreatic lesion by imaging meeting size requirements (short axis 2.0 cm, long axis 6.0 cm)
- Adequate kidney, liver, bone marrow, and coagulation function as defined by lab test thresholds
- Agree to use strict contraception during the study and for 12 months after treatment; negative pregnancy test for females of reproductive age before treatment
You will not qualify if you...
- Allergy to NRT6008 injection or its components
- Contraindications to the chemotherapy regimens used in this study
- Previous anti-tumor treatments for pancreatic cancer (except stopping traditional/herbal medicine 7 days before screening)
- Contraindications to anesthesia
- History of other cancers within 5 years except certain cured skin and early-stage cancers
- Presence or suspected distant metastases
- Pregnant or breastfeeding females
- High risk or difficulty for EUS-guided fine-needle injection
- Tumor invasion into stomach, duodenum, or peritoneum on imaging
- Poorly controlled chronic diseases including hypertension or diabetes
- Recent acute pancreatitis, severe bleeding, severe heart disease, or infections requiring treatment
- Participation in other clinical trials within 1 month before chemotherapy
- Positive HIV test
- Positive hepatitis B or C with active viral replication (some exceptions with antiviral use)
- Syphilis infection or active tuberculosis
- Other reasons making participation unsuitable as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
2
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
3
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
4
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
5
Chongqing University Cancer Hospital
Chongqing, China
Actively Recruiting
6
Tianjin Medical University General Hospital
Tianjin, China
Actively Recruiting
Research Team
Z
Zhaoshen Li, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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