Advanced CancerPhase 3NCT06338683
Survival With Olanzapine in Patients With Locally Advanced or Metastatic Upper Gastrointestinal and Lung Cancer
A Phase 3 study testing Olanzapine 2.5 MG, Standard anti-tumor treatment and Nutritional advice in people with Advanced Cancer and Olanzapine, run by Qinghai Red Cross Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Advanced Cancer, Olanzapine, Progression Free Survival
- What is being tested?
- Olanzapine 2.5 MG, Standard anti-tumor treatment and Nutritional advice
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2024to 20 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
- Expected survival ≥ 3 months;
- The patient is eligible for oral administration without dietary restrictions;
- Exhibits a favorable adherence to treatment and follow-up, demonstrates compliance with the research protocol, and willingly signs the informed consent form.
Who cannot join
- 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;
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
- History of clozapine-induced agranulocytosis because patients will be at increased risk for neutropenia with Olanzapine;
Show all 10Show fewer
- Uncontrolled diabetes mellitus and Uncontrolled seizure disorder;
- Pregnant and Nursing women;
- Exclusion criteria include active participation in another interventional clinical trial, ongoing involvement in an observational (noninterventional) clinical trial, or being in the survival follow-up phase of an interventional clinical trial;
- Researchers posit that any condition deemed potentially harmful to the subjects or that might prevent subjects from meeting or adhering to the research requirements shall not be permissible for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qinghai Red Cross Hospital
Xining, Qinghai, 810000
Qiuxia Dong, Dr, 0971-8267613, 2816278916@qq.com
About this study
Official title: Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical 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.
Read the detailed description
This study is a prospective, randomized, multicenter, open-label clinical trial to evaluate the effect of olanzapine on survival in patients with locally advanced, unresectable, or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung cancer. Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form. Eligible patients will be dynamically randomized in a 1:1 ratio to either the Olanzapine + Nutritional advice + Standard anti-tumor treatment group (ONS group) or the Nutritional advice + Standard anti-tumor treatment group (NS group). The ONS group will receive olanzapine treatment orally until disease progression. Survival outcomes, including median PFS, OS, and ORR, will be monitored during treatment through follow-up assessments.
In addition, baseline and post-treatment weight data will be collected to assess the incidence of weight loss and changes in body mass index (BMI) among patients. Researchers will collect survey questionnaires and conduct blood analyses to evaluate improvements in other symptoms associated with olanzapine and changes in quality of life and inflammatory markers. Primary and secondary study outcomes and adverse events will be assessed.
- Conditions
- Advanced Cancer, Olanzapine, Progression Free Survival
- Being tested
- Olanzapine 2.5 MG, Standard anti-tumor treatment, Nutritional advice
- Keywords
- advanced cancer, olanzapine, chemotherapy, progression free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 2.5 MGDrug
Oral olanzapine 2.5 mg once daily at bedtime until disease progression
Standard anti-tumor treatmentDrug
Clinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation
Nutritional adviceDietary supplement
All patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition
| Study group | Role | What they receive |
|---|---|---|
| Arm I (ONS group) | Experimental | Patients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment. Receives: Drug: Olanzapine 2.5 MG; Drug: Standard anti-tumor treatment; Dietary Supplement: Nutritional advice |
| Arm II (NS group) | Placebo comparator | No Intervention: Patients received nutritional advice and standard anti-tumor treatment. Receives: Drug: Standard anti-tumor treatment; Dietary Supplement: Nutritional advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (12)
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
Measured: 2 years
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
Measured: 2 years
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.
Measured: 2 years
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
Measured: 2 years
Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups
Patients will be asked to fill the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) Anorexia/Cachexia Subscale (A/CS) questionnaire (investigator assisted) for the other symptoms both validated with a set cut-off values before start of chemotherapy treatment and after every 2 weeks. These instruments will be presented to the patients on paper and assistance will be offered if required. Both instruments will be filled out based on the patient's experience regarding their appetite during the last 7 days. The 12 items of the FAACT-A/CS are scored on a five-point Likert scale (0 = not at all, 1 = a little bit, 2 = somewhat, 3 = quite a bit, and 4 = very much). The scores of negatively worded items should be reversed. The sum score ranges from 0 to 48, whereby a lower score indicates less appetite. For scoring the FAACT-A/CS, the FACIT manual will be applied. The cut-off values of ≤37 on the FAACT-A/CS had the highest predictive values.
Measured: 2 years
Comparing the difference in Quality of life in the overall stage between the two groups
Assessment through the EuroQol Five Dimensions Questionnaire (EQ-5D). EQ-5D is a standardized instrument used for assessing an individual's health-related quality of life. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has three levels that describe the person's level of functioning or well-being in that specific area. Additionally, EQ-5D includes a visual analog scale where individuals rate their overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health)
Measured: 2 years
neutrophil-to-lymphocyte ratio
Comparing the difference in Changes in inflammatory factor neutrophil-to-lymphocyte ratio
Measured: 2 years
platelet-to-lymphocyte ratio
Comparing the difference in Changes in inflammatory factor
Measured: 2 years
C-reactive protein (CRP) concentration
Comparing the difference in Changes in inflammatory factor
Measured: 2 years
concentration of albumin
Comparing the difference in Changes in inflammatory factor
Measured: 2 years
Level of interleukin (IL)-6 and IL-8
Comparing the difference in Changes in inflammatory factor , through the examination of blood profiles
Measured: 2 years
Comparing the difference in the side effects of olanzapine treatment between the two groups
The proportion of side effects related to olanzapine treatment in patients evaluated by Common Terminology Criteria for adverse events Version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start20 Mar 2024
- Primary completion20 Mar 2027 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghai Red Cross Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338683
- Sponsor's protocol ID
- QRCH-2024001
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival With the Addition of Olanzapine to Anticancer Therapy in Patients With Locally Advanced, Unresectable or Metastatic Gastric, Esophageal, Hepatopancreaticobiliary and Lung Cancer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06338683
- Acronym / sponsor ID
- QRCH-2024001
- Conditions
- Advanced Cancer, Olanzapine, Progression Free Survival
- Keywords
- advanced cancer, olanzapine, chemotherapy, progression free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Qinghai Red Cross HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 20 Mar 2027 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a prospective, randomized, multicenter, open-label clinical trial to evaluate the effect of olanzapine on survival in patients with locally advanced, unresectable, or metastatic gastric, esophageal, hepato-pancreaticobiliary, and lung cancer. Patients who meet the inclusion and exclusion criteria will be formally enrolled after screening and signing an informed consent form. Eligible patients will be dynamically randomized in a 1:1 ratio to either the Olanzapine + Nutritional advice + Standard anti-tumor treatment group (ONS group) or the Nutritional advice + Standard anti-tumor treatment group (NS group). The ONS group will receive olanzapine treatment orally until disease progression. Survival outcomes, including median PFS, OS, and ORR, will be monitored during treatment through follow-up assessments.
In addition, baseline and post-treatment weight data will be collected to assess the incidence of weight loss and changes in body mass index (BMI) among patients. Researchers will collect survey questionnaires and conduct blood analyses to evaluate improvements in other symptoms associated with olanzapine and changes in quality of life and inflammatory markers. Primary and secondary study outcomes and adverse events will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (ONS group) | Experimental | Drug: Olanzapine 2.5 MG, Drug: Standard anti-tumor treatment, Dietary Supplement: Nutritional advicePatients receive olanzapine 2.5mg PO until disease progression. Intervention: Patients received olanzapine and nutritional advice and standard antitumor treatment. |
| Arm II (NS group) | Placebo comparator | Drug: Standard anti-tumor treatment, Dietary Supplement: Nutritional adviceNo Intervention: Patients received nutritional advice and standard anti-tumor treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
- Expected survival ≥ 3 months;
Key exclusion criteria (10 listed)
- 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;
- Prohibition of Olanzapine Intake for Contraindicated Individuals;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine 2.5 MGOral olanzapine 2.5 mg once daily at bedtime until disease progression | Drug | Arm I (ONS group) |
| Standard anti-tumor treatmentClinicians choose the appropriate standard antitumor drug therapy based on the patient's specific situation | Drug | Arm I (ONS group), Arm II (NS group) |
| Nutritional adviceAll patients enrolled in the study were required to undergo a nutritional assessment and were provided with nutritional advice based on their condition | Dietary supplement | Arm I (ONS group), Arm II (NS group) |
Primary outcome
Comparing the difference in Median PFS between the two groups
Time frame: 2 years
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
12 secondary outcomes
Comparing the difference in Median OS between the two groups
Time frame: 2 years
Comparing the difference in ORR between the two groups
Time frame: 2 years
Comparing the difference in the incidence of ≥3% weight loss between the two groups
Time frame: 2 years
Comparing the difference in BMI between the two groups
Time frame: 2 years
Comparing the difference in the improvement in other symptoms (appetite, nausea, fatigue, insomnia) between the two groups
Time frame: 2 years
Comparing the difference in Quality of life in the overall stage between the two groups
Time frame: 2 years
neutrophil-to-lymphocyte ratio
Time frame: 2 years
platelet-to-lymphocyte ratio
Time frame: 2 years
C-reactive protein (CRP) concentration
Time frame: 2 years
concentration of albumin
Time frame: 2 years
Level of interleukin (IL)-6 and IL-8
Time frame: 2 years
Comparing the difference in the side effects of olanzapine treatment between the two groups
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
Related trials for Advanced Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine 2.5 MG, Standard anti-tumor treatment and Nutritional advice in people with Advanced Cancer and Olanzapine, run by Qinghai Red Cross Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the difference in Median PFS between the two groups (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.