RecruitingPhase 3NCT06500234

Nutrition Impact on Immunotherapy of Cancer

Phase III Study on the Relation of Nutrition and Immunotherapy of Cancer Patients

Sponsor

Qingdao Central Hospital

Enrollment

300 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

This study investigates nutritional status and outcomes of immuntherapy in cancer patients.

Min Age: 18 YearsMax Age: 80 Years

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;

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.

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