Gastric Cancer (Diagnosis)Early Phase 1NCT05908838
Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
A Early Phase 1 study testing Modified Banxia Xiexin Decoction in people with Gastric Cancer (Diagnosis), run by ShuGuang Hospital.
Trial summary
Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape… Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Gastric Cancer (Diagnosis)
- What is being tested?
- Modified Banxia Xiexin Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 2 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with stage IV gastric cancer with a clear cytological or pathological diagnosis.
- The patient is willing to receive palliative chemotherapy (more than 6 months between the first treatment or the last chemotherapy).
- At least one measurable lesion revealed by imaging (PET-CT, CT, MRI, bone scan, x-ray).
- Expected survival of ≥ 6 months.
- It is consistent with the diagnosis of spleen qi deficiency and cold-heat mismatch in TCM.
- Age 18 to 75 years with a physical condition score of ECOG (0-1).
- The blood count is normal, heart, liver and kidney functions are not abnormal, and the electrocardiogram is basically normal.
- Patients have good compliance, are able to understand the study and sign an informed consent form.
Who cannot join
- Those with a history of severe cardiovascular, urinary, hematological and digestive system diseases.
- Pregnant or breastfeeding women with uncontrollable mental disorders.
- With gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia.
- Complications of serious infectious diseases such as active tuberculosis.
- Those with contraindications to chemotherapy or frequent vomiting.
- Poor compliance.
- Patients who have used other trial drugs or in other clinical trials in the past month.
About this study
Official title: Randomized Clinical Trial:Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of Modified Banxia Xiexin Decoction's treatment on gastric cancer
Read the detailed description
Modified Banxia Xiexin Decoction treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and mechanism of Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic Schedule#In this study, 146patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 73 patients in the Modified Banxia Xiexin Decoction combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of life score, Tumor markers, Immune function and adverse reactions of the two groups before and 18 weeks after treatment were observed and compared. Elucidate the possible mechanism of action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.
- Conditions
- Gastric Cancer (Diagnosis)
- Being tested
- Modified Banxia Xiexin Decoction, combination chemotherapy with Placebo granules
- Keywords
- Modified Banxia Xiexin Decoction, Gastric Cancer, Clinical Efficacy, Randomized clinical trial, Mechanism
- Medical subject headings
- Stomach Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Banxia Xiexin DecoctionDrug
The treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and S-1 monotherapy regimen.
combination chemotherapy with Placebo granulesDrug
combination chemotherapy with Placebo granules
| Study group | Role | What they receive |
|---|---|---|
| combination chemotherapy with Modified Banxia Xiexin Decoction | Active comparator | 146 patients with gastric cancer were randomly divided into a treatment group of 73 cases and a control group of 73 cases. The treatment group received combination chemotherapy with Modified Banxia Xiexin Decoction Receives: Drug: Modified Banxia Xiexin Decoction |
| combination chemotherapy with Placebo granules | Placebo comparator | The control group received combination chemotherapy with Placebo granules. Receives: Drug: combination chemotherapy with Placebo granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 18 months.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
Secondary outcomes (5)
Progression-free survival
The time between the first treatment and tumor progression or death.From date of randomization until the date of first documented progression, whichever came first, assessed up to 18 months. To observe the effects of treatment group and control group on PFS in patients with advanced gastric cancer, and evaluate whether there is a statistical difference in PFS between the two groups.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
EORTC QLQ-C30
The quality of life score is based on the EuroPean organization for Research and Treatment (EORTC) Quality of Life Scale (QLQ-C30 v3.0), which records changes in quality of life before and after treatment and compares them. Linear transformation of statistical results was performed to obtain standardized scores (0~100 points), so that scores in various fields could be compared with each other, and the problem of reverse entries could be solved at the same time. The higher the score of symptom field obtained by each subscale, the worse the quality of life condition. The higher the scores in the areas of function and general health, the better the patient's quality of life. Analyze whether there was a statistical difference between the two groups.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
Clinical symptoms
According to the scoring criteria of the Guidelines for Clinical Research of New Chinese Medicines (2002), the symptoms of patients after treatment were determined. The improvement of patients' overall symptoms was evaluated by Nimodipine method, and the efficacy index after treatment = (total score before treatment - total score after treatment)/total score before treatment *100%.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
Tumor markers
Detect the biomarkers (CA72-4, CEA, CA19-9, CA242, CA50, CA125) of two groups of patients before and after treatment to determine whether there is a statistical difference between the two groups before and after treatment.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
Immune function
T cell subsets of the two groups to determine whether there was a statistical difference between the two groups before and after treatment.
Measured: the patients' were included into the clinical trials and up to 18 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start1 Jan 2017
- Primary completion1 Dec 2022
- Study completion2 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer (Diagnosis)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingyu Sun, ShuGuang Hospital
- Investigators
- Mingyu Sun, doctor, Principal investigator, Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908838
- Sponsor's protocol ID
- 42507214-11
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial:Clinical Study of Modified Banxia Xiexin Decoction Treatment on Gastric Cancer
- ClinicalTrials.gov ID
- NCT05908838
- Acronym / sponsor ID
- 42507214-11
- Conditions
- Gastric Cancer (Diagnosis)
- Keywords
- Modified Banxia Xiexin Decoction, Gastric Cancer, Clinical Efficacy, Randomized clinical trial, Mechanism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 2 Dec 2022 (actual)
- First posted
- 18 Jun 2023 (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.
Research purpose To elucidate the effect mechanism and clinical effective of Modified Banxia Xiexin Decoction in the prevention and treatment of gastric cancer. From genes related to cell differentiation, proliferation, apoptosis, tumor invasion and metastasis, genes related to immune inflammation and immune escape and other possible aspects to elucidate the effective and mechanism of Modified Banxia Xiexin Decoction's treatment on gastric cancer
Detailed description
Modified Banxia Xiexin Decoction treatment and mechanism on Gastric Cancer. Main Responsibility Person: Mingyu Sun research center#Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Trial Objective#Observe the clinical efficacy and mechanism of Modified Banxia Xiexin Decoction in the treatment gastric cancer Therapeutic Schedule#In this study, 146patients with gastric cancer who received chemotherapy in the Department of Gastrointestinal Surgery and Oncology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine were recruited and divided into groups according to random number table method, namely, 73 patients in the Modified Banxia Xiexin Decoction combined chemotherapy group and 73 patients in the Placebo granules combined chemotherapy group.Modified Banxia Xiexin Decoction group was treated with 18 weeks of Chinese patent medicine Modified Banxia Xiexin Decoction at the same time of chemotherapy. The Overall survival, Progression-free survival, Solid tumor efficacy, TCM syndrome score, quality of life score, Tumor markers, Immune function and adverse reactions of the two groups before and 18 weeks after treatment were observed and compared. Elucidate the possible mechanism of action of Modified Banxia Xiexin Decoction in the treatment of gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination chemotherapy with Modified Banxia Xiexin Decoction | Active comparator | Drug: Modified Banxia Xiexin Decoction146 patients with gastric cancer were randomly divided into a treatment group of 73 cases and a control group of 73 cases. The treatment group received combination chemotherapy with Modified Banxia Xiexin Decoction |
| combination chemotherapy with Placebo granules | Placebo comparator | Drug: combination chemotherapy with Placebo granulesThe control group received combination chemotherapy with Placebo granules. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with stage IV gastric cancer with a clear cytological or pathological diagnosis.
- The patient is willing to receive palliative chemotherapy (more than 6 months between the first treatment or the last chemotherapy).
- At least one measurable lesion revealed by imaging (PET-CT, CT, MRI, bone scan, x-ray).
- Expected survival of ≥ 6 months.
- It is consistent with the diagnosis of spleen qi deficiency and cold-heat mismatch in TCM.
Key exclusion criteria (7 listed)
- Those with a history of severe cardiovascular, urinary, hematological and digestive system diseases.
- Pregnant or breastfeeding women with uncontrollable mental disorders.
- With gastrointestinal obstruction or active bleeding in the gastrointestinal tract, as well as perforation and dysphagia.
- Complications of serious infectious diseases such as active tuberculosis.
- Those with contraindications to chemotherapy or frequent vomiting.
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 |
|---|---|---|
| Modified Banxia Xiexin DecoctionThe treatment group#Modified Banxia Xiexin Decoction group#was given Modified Banxia Xiexin Decoction, 2 bags each time, 2 times a day, and 1 hour after meals. The control group(chemotherapy group)#Chemotherapy regimen was based on the Chinese Clinical Oncology Association Guidelines for the Diagnosis and Treatment of Gastric Cancer (2018), including oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, and S-1 monotherapy regimen. | Drug | combination chemotherapy with Modified Banxia Xiexin Decoction |
| combination chemotherapy with Placebo granulescombination chemotherapy with Placebo granules | Drug | combination chemotherapy with Placebo granules |
Primary outcome
Overall survival
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
To observe the effects of treatment group and control group on OS in patients with advanced gastric cancer, and evaluate whether there is statistical difference in OS between the two groups.From date of randomization until the date of death from any cause, whichever came first, assessed up to 18 months.
5 secondary outcomes
Progression-free survival
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
EORTC QLQ-C30
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
Clinical symptoms
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
Tumor markers
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
Immune function
Time frame: the patients' were included into the clinical trials and up to 18 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mingyu Sun, doctor principal investigator
Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Modified Banxia Xiexin Decoction in people with Gastric Cancer (Diagnosis), run by ShuGuang Hospital.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: the patients' were included into the clinical trials and up to 18 weeks treatment). 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 18 Jun 2023.