Status:
RECRUITING
A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of pNET
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Pancreatic Neuroendocrine Neoplasm
Sorafenib
Eligibility:
All Genders
18-80 years
Brief Summary
The incidence rate of pancreatic neuroendocrine neoplasms (pNENs) is increasing year by year. According to the statistical results of the SEER (Surveillance, Epidemiology, and End Results) database, t...
Detailed Description
Neuroendocrine neoplasms (NENs) are heterogeneous tumors originating from peptidogenic neurons and neuroendocrine cells. Most commonly found in the digestive tract or lungs, it can be a benign or mali...
Eligibility Criteria
Inclusion
- Patients must have a full understanding of this study and voluntarily sign an informed consent form;
- Age ≥ 18 years old and age ≤ 80 years old;
- Patients with pancreatic neuroendocrine tumors diagnosed by histopathology or cytology, who have progressed after previous treatments such as SSA, targeted therapy, and chemotherapy (all grades of pancreatic neuroendocrine tumors and neuroendocrine cancers are allowed to be included);
- According to the criteria for evaluating the efficacy of solid tumors (RECIST V1.1), there should be at least one measurable lesion;
- At least 7 days have passed since the end of the last systemic treatment, and palliative radiotherapy for localized areas is allowed. It has been completed for more than 4 weeks;
- Expected survival time ≥ 12 weeks;
- Researchers estimate that patients can benefit from it;
- The patients have sufficient organ and bone marrow function;
- Male or female patients with fertility voluntarily use effective contraceptive methods, such as double barrier contraception, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered to have fertility unless they have undergone natural menopause, artificial menopause, or sterilization surgery (such as hysterectomy, bilateral adnexectomy, or radiation ovarian irradiation).
Exclusion
- Other malignant tumors have been diagnosed in the past 5 years, except for effectively treated skin basal cell carcinoma, skin squamous cell carcinoma, or effectively resected cervical carcinoma in situ, breast cancer;
- Simultaneously receiving other investigational drugs or approved or investigational anti-tumor treatments;
- Patients with contraindications to experimental drugs (such as active bleeding, ulcers, intestinal perforation, intestinal obstruction, uncontrolled hypertension, III-IV grade heart failure, within 30 days after major surgery, severe liver and kidney dysfunction, etc.);
- The patient currently has any diseases or conditions that affect drug absorption, or the patient is unable to take oral medication;
- Confirmed allergy to any component of the investigational drug and/or its excipients;
- Pregnant (positive pregnancy test before medication) or breastfeeding women;
- Patients with large amounts of pleural effusion or ascites requiring drainage;
- Any other disease with clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory examination abnormalities. According to the researcher's judgment, it is suspected that the patient has a certain disease or condition that is not suitable for the use of the study drug (such as having seizures and requiring treatment), or that it will affect the interpretation of the study results, or put the patient in a high-risk situation;
- Have taken medication containing components of Hypericum perforatum within 3 weeks prior to the first study medication. Or have taken other strong inducers or inhibitors of CYP3A4 within the previous 2 weeks;
- According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study or are not suitable for inclusion, such as other serious concomitant diseases (such as severe diabetes, thyroid disease, spinal cord compression, superior vena cava syndrome, mental illness), serious laboratory examination abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples).
Key Trial Info
Start Date :
September 30 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06592989
Start Date
September 30 2024
End Date
September 30 2026
Last Update
January 10 2025
Active Locations (1)
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1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080