Nutrition Impact on Immunotherapy of Cancer (NCT06500234) | Clinical Trial Compass
RecruitingPhase 3
Nutrition Impact on Immunotherapy of Cancer
China300 participantsStarted 2024-06-01
Plain-language summary
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Diagnosis of cancer, malnutrition Age \>18 years Performance status ECOG of 0 or 2. Life expectancy ≥ 6 months. At least one lesion measurable as defined by standard imaging criteria for the patient's tumor type (RECIST v1.1) Patients must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment Postmenopausal or evidence of non-childbearing status for women of childbearing potential Patient is willing and able to comply with the protocol for the duration of the study.
For all oral medications patients must be able to comfortably swallow capsules;
Exclusion Criteria:
* Patients unable to swallow orally administered medication and patients with Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs History of allogenic organ, bone marrow or double umbilical cord blood transplantation.
Active or prior documented autoimmune or inflammatory disorders Uncontrolled intercurrent illness or patient considered a poor medical risk due to a serious, uncontrolled medical disorder, including but not limited to, ongoing or active infection, symptomatic congestive heart failure Currently taking medications with known risk of prolonging the QT interval or inducing Torsades de Pointes.