Actively Recruiting
HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
Led by Zhejiang University · Updated on 2025-09-23
32
Participants Needed
2
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.
CONDITIONS
Official Title
HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Diagnosed with metastatic pancreatic cancer from pancreatic ductal epithelium
- Tumor tissue confirmed to have KRAS G12D mutation
- No prior systemic antitumor therapy in advanced stage; previous neoadjuvant or adjuvant therapy must have ended over 6 months ago
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Vital organ functions meet specified blood count and biochemical criteria
- No use of blood components or cell growth factors within 2 weeks prior to enrollment
- Women of childbearing age must have a negative pregnancy test within 7 days before enrollment, be non-lactating, and agree to use contraception during and for 6 months after treatment
- Men must be surgically sterilized or agree to use contraception during and for 6 months after treatment
- Willingness to participate, good compliance, and agreement to follow-up
You will not qualify if you...
- Prior targeted therapy against KRAS G12D or EGFR
- Major surgery or major trauma within 4 weeks before enrollment
- Palliative local treatments within 2 weeks before enrollment
- Participation in other clinical trials with investigational medication within 4 weeks before enrollment
- Use of drugs strongly affecting CYP3A4 or CYP2C8 enzymes within 14 days before enrollment
- Presence of central nervous system metastases
- Acute or chronic pancreatitis requiring clinical intervention
- Gastrointestinal obstruction within 6 months before treatment unless fully resolved by surgery
- Unstable third space effusion within 2 weeks before enrollment
- Severe infection or fever of unknown cause (>38.5°C) within 4 weeks before enrollment
- Severe cardiovascular or cerebrovascular disease
- Known or suspected interstitial pneumonia except minor imaging changes
- History of serious neurological or psychiatric disorders
- Presence of non-healing wounds or uncured fractures
- Unresolved adverse events from prior treatments except alopecia
- Other malignancies within 5 years except certain low-risk cancers
- Active hepatitis B, hepatitis C, HIV, syphilis, or active or recent tuberculosis
- Known allergy to any study drug components
- Any other factors that may affect study results or lead to study termination as judged by investigators
AI-Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Zhejiang University Schlool of Medicine
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
2
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
T
Tingbo Liang, MD
CONTACT
Y
Yiwen Chen, 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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