Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer

Trial ID: NCT06017284

Interventional - Phase 3 - Recruiting

The purpose of this study is to evaluate the efficacy of thalidomide on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.

Conditions

• Pancreatic Cancer Stage IV
• Chemotherapy-induced Nausea and Vomiting

Interventions

• Thalidomide
• Nab paclitaxel
• Gemcitabine
• Placebo

Eligibility

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.

Sponsor

Fudan University

Source: ClinicalTrials.gov

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