Status:
RECRUITING
Nutrition Impact on Immunotherapy of Cancer
Lead Sponsor:
Qingdao Central Hospital
Conditions:
Nutrition Disorders
Immunotherapy
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study investigates nutritional status and outcomes of immuntherapy in cancer patients.
Detailed Description
Studies have shown that more than half of the patients with cancer are also malnourished at diagnosis. This increases patients' risk of complications associated with the treatment as well as the aband...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06500234
Start Date
June 1 2024
End Date
May 31 2027
Last Update
July 15 2024
Active Locations (1)
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1
Qingdao Central Hospital
Qingdao, Shandong, China, 266042