Actively Recruiting
HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma
Led by West China Hospital · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
107 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety and efficacy of HRS-4642 combined with Nimotuzumab in patients with recurrent or metastatic pancreatic ductal adenocarcinoma.
CONDITIONS
Official Title
HRS-4642 Combined With Nimotuzumab in the Treatment of Recurrent or Metastatic Pancreatic Ductal Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-75 years (including 18 and 75 years).
- Pancreatic ductal adenocarcinoma confirmed by pathology (histology) or cytology.
- Patients with metastatic pancreatic ductal adenocarcinoma.
- At least one measurable lesion by imaging (diameter 10 mm or lymph node diameter 15 mm) per RECIST 1.1.
- Physical condition score ECOG 0-2.
- Expected survival of 12 weeks or longer.
- Normal major organ function.
- Adverse events from previous anti-tumor therapy resolved to grade 1 or as specified; stable type 1 diabetes and hypothyroidism allowed.
- Fertile females must have a negative pregnancy test within 7 days before first dose and must not be breastfeeding; contraceptive use required during and 30 days after treatment.
- Voluntary informed consent with good compliance and follow-up ability.
You will not qualify if you...
- Previous use of KRAS inhibitors or targeted EGFR therapy.
- Known allergy to the study drugs or components.
- Systemic antitumor therapy within 28 days prior to first dose, except oral fluorouracil and small molecule drugs within 14 days or 5 half-lives; recent surgery within 28 days; local treatments within 14 days.
- Other active or recent malignant tumors except certain skin, bladder, cervical, prostate, breast, or thyroid cancers in complete remission for at least 2 years.
- Untreated or active central nervous system tumor metastasis or meningeal metastasis.
- Severe cardiovascular or cerebrovascular events within 6 months, NYHA grade 2 or above cardiac dysfunction, or significant arrhythmias.
- Digestive tract obstruction within 6 months unless fully resolved by surgery.
- Bleeding from esophageal or gastric varices within 3 months.
- Severe varicose veins or portal hypertension with bleeding risk.
- Advanced symptomatic patients with uncontrolled large effusions, unless stable for at least 2 weeks after drainage.
- Serious pulmonary diseases or recent major surgery within 28 days.
- Active or untreated tuberculosis.
- Immune deficiencies including HIV, active hepatitis B or C, or co-infections.
- Significant pancreatitis or high risk for pancreatitis.
- Use of live attenuated vaccine within 28 days before treatment.
- Participation in another clinical trial within 4 weeks.
- Uncontrollable mental illness, substance abuse, or other conditions affecting study completion.
- Other conditions judged by researchers to preclude participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
D
Dan Cao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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