Health TrialsbyHealthPanel

Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer

ConditionsAdvanced CancerOlanzapineProgression Free Survival
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQinghai Red Cross Hospital

About this trial

This study aims to assess the impact of adding olanzapine to nutritional advice and standard anti-tumor therapy on the survival and safety of patients with locally advanced, unresectable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer, and lung cancer. Researchers seek to determine whether olanzapine can improve progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) in advanced cancer patients who received standard anti-tumor therapy, and investigate the relationship between olanzapine-induced weight changes and patient survival.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18 years or older;

Eastern Cooperative Oncology Group performance status of 0-3;

Stage III or IV inoperable or metastatic gastric cancer, esophageal cancer, hepato-pancreaticobiliary cancer and lung cancer confirmed by histology or cytology;

Subjected to palliative systemic chemotherapy, regardless of first-line or second-line treatment;

Disqualifiers

Weight loss and gain may be attributed to alternative factors, such as edema or ascites;

Suffers from mental disorders or is under the medication of any antipsychotic or antidepressant drugs;

History of central nervous system disorders (such as brain metastasis, epilepsy;

Patients undergoing sustained administration of sedative medications or long-term hormonal therapy, individuals with chronic alcoholism, or those with substance dependence on medications;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Olanzapine 2.5 MG

    Drug

    Oral olanzapine 2.5 mg once daily at bedtime until disease progression

  • Standard anti-tumor treatment

    Drug

    Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation

  • Nutritional advice

    Dietary supplement

    All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Arm I (ONS group)Experimental treatment 3 interventions
Group B: Arm II (NS group)Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Comparing the difference in Median PFS between the two groups

PFS was defined as the time between the start of treatment in this study and the onset of (any aspect of) tumor progression or death (from any cause). Assessment through the RECICT 1.1 version of solid tumors

Time frame
2 years

Secondary outcomes

1

Comparing the difference in Median OS between the two groups

OS was defined as the time from the start of randomization to death due to any cause. Assessment through the RECICT 1.1 version of solid tumors

Time frame
2 years
2

Comparing the difference in ORR between the two groups

ORR was defined as the proportion of patients with advanced disease who achieved complete or partial remission after treatment. Assessment through the RECICT 1.1 version of solid tumors

Time frame
2 years
3

Comparing the difference in the incidence of ≥3% weight loss between the two groups

Patients will receive weight measurements every 2 cycles. Over a 2-year period, the incidence of ≥3% weight loss until progression between the two groups will be assessed based on patients' baseline and post-treatment measurements to determine the efficacy of the drug.

Time frame
2 years
4

Comparing the difference in BMI between the two groups

The BMI will be calculated by dividing weight in Kg with the square of the body height (in m2), and is expressed in units of kg/m2. Weight will be recorded by a high quality calibrated digital scale. Participants would be instructed to keep light cloths according to their comfort and no foot-ware. Weight will be expressed in kilograms (Kg) and same machine will be used during each recoding, preferably during the same hour of the day. Height will be measured using a stadiometer, in centimeters (cm) using the metric system. Comparison of BMI (BMI \<20 kg/m2; BMI 20-25 kg/m2; BMI \>25 kg/m2) between the two groups

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qinghai Red Cross Hospital

Lead sponsor

Source ClinicalTrials.gov
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