Actively Recruiting
Phase II Study of HRS-4642 Combined With Nimotuzumab and Chemotherapy for Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation
Led by Zhejiang University · Updated on 2026-02-13
40
Participants Needed
2
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a combination treatment using HRS-4642, Nimotuzumab, and chemotherapy (AG regimen) in adults with borderline resectable pancreatic cancer that has a specific KRAS G12D mutation. This is a Phase II clinical trial designed to study this combination in 40 patients and includes a screening period, treatment period, and follow-up period to monitor safety and survival. During the treatment phase, participants receive neoadjuvant therapy with HRS-4642 given intravenously on Days 1 and 8 every three weeks, Nimotuzumab on Days 1 and 8 every three weeks, and chemotherapy drugs albumin-bound paclitaxel and gemcitabine on Days 1 and 8 every three weeks for four cycles. After two and four cycles, imaging is done to evaluate response. If surgery is feasible after neoadjuvant therapy, participants undergo surgery followed by an adjuvant therapy phase with the same drug combination for up to four cycles. If surgery is not possible and the disease has not progressed, treatment may continue as assessed by the investigator. Participants have regular visits for treatment and assessments, including tumor imaging at specific cycles and intervals after surgery or if surgery is not performed. After treatment ends, participants return for a safety follow-up visit about 30 days later and enter a survival follow-up phase with monitoring every two months until death, loss to follow-up, or study termination. The primary outcome is the 12-month event-free survival rate, with other outcomes including overall survival, surgical rates, and response rates.
CONDITIONS
Brief Title
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years (inclusive).
- Histopathologically confirmed pancreatic cancer from the pancreatic ductal epithelium.
- Radiologically confirmed borderline resectable pancreatic cancer with no distant metastases.
- Tumor tissue confirmed to have KRAS G12D mutation.
- No prior systemic anti-tumor therapy.
- At least one lesion measurable by RECIST v1.1 criteria.
- ECOG performance status of 0 or 1.
- Expected survival time of at least 3 months.
- Adequate organ function meeting specified blood counts, liver and kidney function, heart function, and ECG criteria.
- Women of childbearing potential must have negative pregnancy test, be non-lactating, and use contraception during and 6 months after treatment; men must be sterile or use contraception during and 6 months after treatment.
- Voluntary informed consent and ability to comply with study procedures and follow-up.
You will not qualify if you...
- Major surgery or significant trauma within 4 weeks before enrollment; palliative local therapy within 2 weeks.
- Treatment with investigational drugs from other clinical studies within 4 weeks, except observational studies.
- Use of strong CYP3A4 or CYP2C8 enzyme inhibitors or inducers within 14 days.
- Acute or chronic pancreatitis requiring intervention.
- Gastrointestinal obstruction symptoms within 6 months, unless resolved by surgery.
- Unstable third-space fluid accumulation within 2 weeks.
- Severe infection or fever above 38.5°C within 2 to 4 weeks.
- Severe cardiovascular or cerebrovascular diseases including recent thrombotic events, myocardial infarction, unstable angina, heart failure NYHA class II or above, or serious arrhythmias.
- Known or suspected interstitial lung disease with clinical symptoms.
- History of neurological or psychiatric disorders including epilepsy or dementia.
- Non-healed wounds or fractures.
- Unresolved adverse events from prior cancer therapy above grade 1.
- History of other malignancies within 5 years except certain low-risk cancers.
- Active infectious diseases such as hepatitis B or C, HIV, syphilis, or tuberculosis.
- Known allergies to study drugs or related compounds.
- Other medical or social conditions that may affect safety or study results as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Approximately 24 weeks (4 cycles of 3 weeks each for neoadjuvant therapy plus up to 4 cycles of adjuvant therapy and surgery timing)
Participants receive neoadjuvant therapy with HRS-4642 in combination with Nimotuzumab and chemotherapy in 4 cycles, followed by assessment for surgery eligibility. If eligible, participants undergo radical surgery within 4 weeks after neoadjuvant therapy, then receive adjuvant therapy with the same regimen for up to 4 cycles. Participants who are not eligible for surgery may continue study treatment if beneficial.
Visits on Day 1 and Day 8 of each cycle, plus Cycle 1 Day 15; tumor imaging at Cycle 3 Day 1 and Cycle 4 Day 21; additional assessments every 12 weeks after surgery or every 6 weeks if no surgery
Duration - Until death, loss to follow-up, or study termination
After stopping study treatment, participants return for a safety follow-up visit about 30 days later, then enter a survival follow-up period with assessments every 2 months until death or study termination.
Safety follow-up 1 visit approximately 30 days after last dose; survival follow-up visits every 2 months
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
Y
Yiwen Chen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here