Gastric Cancer (Diagnosis)Early Phase 1NCT05888675
Clinical Study of Weifuchun Treatment on Gastric Cancer
A Early Phase 1 study testing Weifuchun in people with Gastric Cancer (Diagnosis), run by ShuGuang Hospital.
Trial summary
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer (Diagnosis)
- What is being tested?
- Weifuchun
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 1 Oct 2020
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should be aged between 18 and 70 years old (including 18 and 70 years old) and their gender is not limited.
- Pathological diagnosis of gastric malignant tumor;
- The pathological types were adenocarcinoma, tubular adenocarcinoma, mucous adenocarcinoma and sig-ring cell carcinoma (including adenocarcinoma and some sig-ring cell carcinoma);
- Patients were willing to receive chemotherapy (oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, or Ticeo monotherapy regimen).
- The patient was willing to receive weifunchun treatment.
Who cannot join
- Incomplete pathological diagnostic data;
- Patients with severe heart, lung, liver, kidney (creatinine greater than the upper limit of the normal range), endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
- Pregnant or lactating women, as well as pregnant persons who may not have taken effective contraceptive measures;
- People who are allergic (allergic to two or more kinds of food, drugs, etc.) or are allergic to known ingredients of the medicine;
- Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
- Patients enrolled in other clinical trials within the last 1 month.
About this study
Official title: Randomized Clinical Trial:Clinical Study of Weifuchun Treatment on Gastric Cancer
Research purpose To elucidate the effect mechanism and clinical effective of weifuchun 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 weifuchun's treatment on gastric cancer.
Read the detailed description
Weifuchun 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 Weifuchun in the treatment gastric cancer Therapeutic Schedule#In this study, 72 patients 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, 36 patients in the Weifichun combined chemotherapy group and 36 patients in the chemotherapy group alone. Weichun group was treated with 24 weeks of Chinese patent medicine Weichun tablet at the same time of chemotherapy. The physical status score, TCM syndrome score, quality of life score, bone marrow suppression and tumor index of the two groups before and 24 weeks after treatment were observed and compared.Fecal samples of the above patients before and after the entry and exit groups were collected, screened and submitted for examination. Finally, 15 cases were submitted for examination in the Weifichun combined chemotherapy group and chemotherapy group alone, and 10 cases were submitted for examination in the healthy volunteers. Miseq platform was used to conduct high-throughput sequencing and analysis of 16S ribosomal RNA of intestinal flora, fecal quality assessment of intestinal flora tested was conducted, α diversity and β diversity were analyzed, and the flora structure, including the level of taxonomy, family, genus, etc., were compared to analyze the differences in each group, and elucidate the possible mechanism of action of Weichun in the treatment of gastric cancer patients.
- Conditions
- Gastric Cancer (Diagnosis)
- Being tested
- Weifuchun
- Keywords
- Weifu Chun, 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.
WeifuchunDrug
The treatment group#Weifuchun group#was given Weifuchun tablets, 4 tablets each time, 3 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 Ticeo monotherapy regimen.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Study of Weifuchun Treatment on Gastric Cancer | Other | 72 patients with gastric cancer were randomly divided into a treatment group of 36 cases and a control group of 36 cases. The treatment group received combination chemotherapy with Weifuchun tablets, while the control group received monotherapy chemotherapy. Receives: Drug: Weifuchun |
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 24 months.
Measured: the patients' were included into the clinical trials and up to 24 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 24 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 24 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 24 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 24 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 24 weeks treatment.
Immune function
T cell subsets of the two groups were detected before and after treatment 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 24 weeks treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jul 2016
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT05888675
- Sponsor's protocol ID
- 42507214-10
- Status last verified
- Jul 2023
- First submitted
- 28 Apr 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- 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 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial:Clinical Study of Weifuchun Treatment on Gastric Cancer
- ClinicalTrials.gov ID
- NCT05888675
- Acronym / sponsor ID
- 42507214-10
- Conditions
- Gastric Cancer (Diagnosis)
- Keywords
- Weifu Chun, Gastric Cancer, Clinical Efficacy, randomized clinical trial, mechanism
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 5 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 weifuchun 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 weifuchun's treatment on gastric cancer.
Detailed description
Weifuchun 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 Weifuchun in the treatment gastric cancer Therapeutic Schedule#In this study, 72 patients 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, 36 patients in the Weifichun combined chemotherapy group and 36 patients in the chemotherapy group alone. Weichun group was treated with 24 weeks of Chinese patent medicine Weichun tablet at the same time of chemotherapy. The physical status score, TCM syndrome score, quality of life score, bone marrow suppression and tumor index of the two groups before and 24 weeks after treatment were observed and compared.Fecal samples of the above patients before and after the entry and exit groups were collected, screened and submitted for examination. Finally, 15 cases were submitted for examination in the Weifichun combined chemotherapy group and chemotherapy group alone, and 10 cases were submitted for examination in the healthy volunteers. Miseq platform was used to conduct high-throughput sequencing and analysis of 16S ribosomal RNA of intestinal flora, fecal quality assessment of intestinal flora tested was conducted, α diversity and β diversity were analyzed, and the flora structure, including the level of taxonomy, family, genus, etc., were compared to analyze the differences in each group, and elucidate the possible mechanism of action of Weichun in the treatment of gastric cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Study of Weifuchun Treatment on Gastric Cancer | Other | Drug: Weifuchun72 patients with gastric cancer were randomly divided into a treatment group of 36 cases and a control group of 36 cases. The treatment group received combination chemotherapy with Weifuchun tablets, while the control group received monotherapy chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients should be aged between 18 and 70 years old (including 18 and 70 years old) and their gender is not limited.
- Pathological diagnosis of gastric malignant tumor;
- The pathological types were adenocarcinoma, tubular adenocarcinoma, mucous adenocarcinoma and sig-ring cell carcinoma (including adenocarcinoma and some sig-ring cell carcinoma);
- Patients were willing to receive chemotherapy (oxaliplatin +5-FU/CF, SOX regimen, XELOX regimen, or Ticeo monotherapy regimen).
- The patient was willing to receive weifunchun treatment.
Key exclusion criteria (6 listed)
- Incomplete pathological diagnostic data;
- Patients with severe heart, lung, liver, kidney (creatinine greater than the upper limit of the normal range), endocrine, hematopoietic system or psychiatric diseases were considered not suitable for the study group;
- Pregnant or lactating women, as well as pregnant persons who may not have taken effective contraceptive measures;
- People who are allergic (allergic to two or more kinds of food, drugs, etc.) or are allergic to known ingredients of the medicine;
- Patients with other medical conditions that interfere with the trial and are deemed unsuitable for inclusion in the trial by the investigator;
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 |
|---|---|---|
| WeifuchunThe treatment group#Weifuchun group#was given Weifuchun tablets, 4 tablets each time, 3 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 Ticeo monotherapy regimen. | Drug | Clinical Study of Weifuchun Treatment on Gastric Cancer |
Primary outcome
Overall survival
Time frame: the patients' were included into the clinical trials and up to 24 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 24 months.
5 secondary outcomes
Progression-free survival
Time frame: the patients' were included into the clinical trials and up to 24 weeks treatment.
EORTC QLQ-C30
Time frame: the patients' were included into the clinical trials and up to 24 weeks treatment.
Clinical symptoms
Time frame: the patients' were included into the clinical trials and up to 24 weeks treatment.
Tumor markers
Time frame: the patients' were included into the clinical trials and up to 24 weeks treatment.
Immune function
Time frame: the patients' were included into the clinical trials and up to 24 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 25 Jul 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 Weifuchun 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 5 inclusion and 6 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 25 Jul 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. 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 24 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 25 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.