Combining Sorafenib and Gefitinib for treating pancreatic neuroendocrine tumors

A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of Pancreatic Neuroendocrine Tumor Patients Who Have Progressed After Previous Treatment

This study is testing if combining two medications, sorafenib and gefitinib, can help people with pancreatic neuroendocrine tumors who haven't responded to other treatments.

Quick facts

• Study type: Observational
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, radiation, sunitinib, Sofantinib, gefitinib, bevacizumab, erlotinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06592989 on ClinicalTrials.gov

What this trial studies

This clinical study investigates the effectiveness of combining sorafenib and gefitinib in patients with pancreatic neuroendocrine tumors (pNET) who have shown progression after previous treatments. The study aims to evaluate the response rates and overall survival of patients receiving this combination therapy. Participants must have measurable lesions and meet specific eligibility criteria, including sufficient organ function and expected survival time. The study is observational, focusing on real-world outcomes rather than controlled experimental conditions.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with histologically confirmed pancreatic neuroendocrine tumors that have progressed after prior therapies.

Not a fit: Patients with early-stage pancreatic neuroendocrine tumors or those who have not undergone previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with advanced pancreatic neuroendocrine tumors.

How similar studies have performed: While there have been successful studies using targeted therapies for neuroendocrine tumors, the specific combination of sorafenib and gefitinib in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients must have a full understanding of this study and voluntarily sign an informed consent form;
2. Age ≥ 18 years old and age ≤ 80 years old;
3. 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);
4. According to the criteria for evaluating the efficacy of solid tumors (RECIST V1.1), there should be at least one measurable lesion;
5. 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;
6. Expected survival time ≥ 12 weeks;
7. Researchers estimate that patients can benefit from it;
8. The patients have sufficient organ and bone marrow function;
9. 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 Criteria:

1. 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;
2. Simultaneously receiving other investigational drugs or approved or investigational anti-tumor treatments;
3. 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.);
4. The patient currently has any diseases or conditions that affect drug absorption, or the patient is unable to take oral medication;
5. Confirmed allergy to any component of the investigational drug and/or its excipients;
6. Pregnant (positive pregnancy test before medication) or breastfeeding women;
7. Patients with large amounts of pleural effusion or ascites requiring drainage;
8. 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;
9. 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;
10. 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).

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiuliang Yan, M.D. — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
• Study coordinator: Jiuliang Yan, M.D.

Conditions Pancreatic Neuroendocrine Neoplasm; Sorafenib; Gefitinib