NCT05888675

Brief 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 aspects to elucidate the effective and mechanism of weifuchun's treatment on gastric cancer.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jul 2016

Longer than P75 for early_phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

4.3 years

First QC Date

April 28, 2023

Last Update Submit

July 23, 2023

Conditions

Gastric Cancer (Diagnosis)

Keywords

Weifu ChunGastric CancerClinical Efficacyrandomized clinical trialmechanism

Outcome Measures

Primary Outcomes (1)

  • 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.

    the patients' were included into the clinical trials and up to 24 weeks treatment.

Secondary Outcomes (5)

  • Progression-free survival

    the patients' were included into the clinical trials and up to 24 weeks treatment.

  • EORTC QLQ-C30

    the patients' were included into the clinical trials and up to 24 weeks treatment.

  • Clinical symptoms

    the patients' were included into the clinical trials and up to 24 weeks treatment.

  • Tumor markers

    the patients' were included into the clinical trials and up to 24 weeks treatment.

  • Immune function

    the patients' were included into the clinical trials and up to 24 weeks treatment.

Study Arms (1)

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.

Drug: Weifuchun

Interventions

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.

Clinical Study of Weifuchun Treatment on Gastric Cancer

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 enrolled in other clinical trials within the last 1 month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach NeoplasmsDisease

Interventions

weifuchun

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mingyu Sun, doctor

    Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

April 28, 2023

First Posted

June 5, 2023

Study Start

July 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

July 25, 2023

Record last verified: 2023-07