Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

Launched by FUDAN UNIVERSITY · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called thalidomide on reducing nausea and vomiting caused by chemotherapy in patients with advanced pancreatic cancer. The goal is to see if thalidomide can improve the quality of life for patients receiving a specific chemotherapy treatment known as gemcitabine and nab-paclitaxel. The trial is currently looking for participants aged 18 to 80 who have been diagnosed with metastatic pancreatic adenocarcinoma and meet certain health criteria.

To be eligible for this trial, participants must be able to understand and agree to the study procedures and have a measurable cancer lesion. However, those who have received prior cancer treatment, have certain digestive tract conditions, or severe other health issues may not qualify. If you join the study, you will receive the trial treatment and be closely monitored for any side effects or improvements in your symptoms. It’s also important to know that both men and women who can get pregnant will need to use contraception during the study. This trial aims to provide hope for better management of chemotherapy-related nausea, which can significantly affect daily life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Ability to understand and the willingness to sign a written informed consent document.
• • Age ≥ 18 years and ≤ 80 years.
• • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• • Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
• • Adequate organ performance based on laboratory blood tests.
• • Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• • The expected survival ≥ 3 months.
• • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
• Exclusion Criteria:
• • Patients who have received any form of anti-tumor therapy.
• • The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas.
• • Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc.
• • Pregnant or nursing women.
• • Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc).
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study.
• • Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
• • Patients who are unwilling or unable to comply with study procedures.