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Gastric CarcinomaPhase 4NCT05229809

Clinical Trial of Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer

A Phase 4 study testing Yiqi Wenyang Jiedu prescription and Simulation agent of Yiqi Wenyang Jiedu prescription in people with Gastric Carcinoma, run by Jie Li at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Carcinoma
What is being tested?
Yiqi Wenyang Jiedu prescription and Simulation agent of Yiqi Wenyang Jiedu prescription
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
212 participants
Where
6 sitesChina
Study dates
1 Mar 2022to 31 Jul 2024
Phase
Phase 4
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The non-esophagogastric junction gastric cancer of stage II-III that met the diagnostic criteria, and no tumor recurrence and metastasis was determined by imaging;
  • Within 6-8 months after radical gastrectomy for gastric cancer (R0), adjuvant chemotherapy of standard regimen (XELOX and SOX) has been completed for at least 6 cycles;
  • ECOG score 0-2;
  • 18-75 years old, male or female;
  • The expected survival time is ≥3 months;
  • Voluntary participation in the study, signing informed consent, good compliance with follow-up.

Who cannot join

  • Patients with other primary tumors;
  • Gastric cancer patients were pathologically diagnosed as adenosquamous carcinoma, with lymphoid stromal carcinoma (medullary carcinoma), hepatoid adenocarcinoma, squamous cell carcinoma, signed-ring cell carcinoma, undifferentiated carcinoma, gastric neuroendocrine tumor, gastric mesenchymal tumor, gastric malignant lymphoma and other gastric malignancies;
  • Patients who had previously received preoperative neoadjuvant chemotherapy;
  • Patients with past or current targeted drug therapy;
  • Patients undergoing previous or ongoing gastric radiotherapy;
  • Patients with past or ongoing tumor immunotherapy;
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  • Mental patients;
  • Patients with serious and uncontrolled organic diseases or infections, such as decompensated heart, lung and renal failure, which lead to intolerance of chemotherapy;
  • Patients who received clinical trials of small molecule drugs within 28 days or large molecule drugs within 3 months;
  • Patients who are known to be allergic or intolerant to the study drug.

Trial locations and contacts

6 sites in 1 country.

Guanghui Zhu, Doctor contact

+86 13315714979

zhugh0822@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Hong Zhao

    Recruiting

  • Xiyuan Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100091

    Yu Wu

    Recruiting

  • Wangjing Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing Municipality, 100102

    Shijie Zhu

    Recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510405

    Lizhu Lin

    Recruiting

  • Jiangsu Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu, 210004

    Peng Shu

    Recruiting

  • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200437

    Ling Xu

    Recruiting

Other trials in China

About this study

Official title: Yiqi Wenyang Jiedu Prescription in the Prevention and Treatment of Postoperative Metastasis and Recurrence of Gastric Cancer：A Randomized, Double-blind, Controlled and Multi-center Clinical Study

The purpose of this study is to evaluate the efficacy and safety of Yiqi Wenyang Jiedu prescription for postoperative gastric cancer.

Read the detailed description

This study include a multicenter, randomized, double-blind, placebo, parallel controlled clinical trial.The randomized clinical trial will enroll approximately 212 patients. Participants will be randomly divided into experimental (n=106) and control groups (n=106).Patients in the experimental group was treated with Yiqiuyang Jiedu prescription within 6-8 months after radical gastroctomy and after the completion of standard regimen (XELOX and SOX) for at least 6 cycles of adjuvant chemotherapy. Patients in the control group will receive the placebo.The primary endpoint is 2-year DFS (Disease-free survival) rate after surgery, that refers to the proportion of patients who do not have recurrence, metastasis or death (from any cause) within 2 years after surgery. The research protocol was approved by the relevant ethics committees, and the study was conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Patients gave written informed consent to participate in the trial.

Being tested
Yiqi Wenyang Jiedu prescription, Simulation agent of Yiqi Wenyang Jiedu prescription
Keywords
Postoperative gastric cancer, Yiqi Wenyang Jiedu prescription, Chinese Herbal Medicine, Randomized Controlled Trial, 2-year disease-free survival rate
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Yiqi Wenyang Jiedu prescriptionDrug

    The dosage form of the test drug is granule. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.

  • Simulation agent of Yiqi Wenyang Jiedu prescriptionDrug

    It is prepared from maltodextrin and food coloring. The raw materials of maltodextrin conform to the relevant provisions of excipients - maltodextrin in the fourth part of Chinese Pharmacopoeia 2015 edition. Food coloring includes caramel coloring, egg yolk coloring and milk chocolate brown pigment, all of which are edible grade ingredients. Patients need to take 2 small packets in the morning and 2 small packets in the evening. The medicine needs to be melted in hot water before being taken. Every 4 weeks is a course of treatment, a total of 6 courses,The patients were followed up to 3 years after gastric cancer surgery.

Study groups in NCT05229809
Study groupRoleWhat they receive
Yiqi Wenyang Jiedu prescription GroupExperimentalNot described
Receives: Drug: Yiqi Wenyang Jiedu prescription
Simulation agent of Yiqi Wenyang Jiedu prescription GroupPlacebo comparatorNot described
Receives: Drug: Simulation agent of Yiqi Wenyang Jiedu prescription

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2-year disease-free survival rate

    Refers to the proportion of patients who did not experience recurrence, metastasis or death (from any cause) within 2 years after surgery.

    Measured: The day of surgery until the second year.

Secondary outcomes (13)

  1. Disease-free survival

    It is the time from randomization to tumor progression or death (from any cause).

    Measured: Randomization until disease recurrence, metastasis, death (from any cause) , or 36 months after surgery, whichever occurs first.

  2. Overall survival

    It is the time from randomization to death (from any cause).

    Measured: Randomization until death (from any cause) or 36 months after surgery, whichever occurs first.

  3. Cumulative annual recurrence and metastasis rate for 1-3 years

    Refers to the proportion of patients with recurrence and metastasis within 1-3 years from the day of surgery.

    Measured: The day of surgery until the once, second and third year.

  4. Cumulative annual survival rate for 1-3 years

    Refers to the proportion of patients with survical within 1-3 years from the day of surgery.

    Measured: The day of surgery until the once, second and third year.

  5. Indexes related to fat distribution

    Total Fat Area, Visceral Fat Area and Subcutaneous Fat Area. They measure fat area on cross-sectional images using plain CT scanning.

    Measured: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).

  6. Visceral Adiposity Index

    It is a new assessment of visceral fat based on waist circumference (WC), BMI, triglyceride (TG) and HDL.

    Male VAI = during [WC/(39.68 + 1.88 x BMI)] * (TG / 1.03) * (1.31 / HDL). Female VAI = during [WC/(36.58 + 1.89 x BMI)] * (TG / 0.81) * (1.52 / HDL).

    Measured: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).

  7. Tumor marker

    CEA, CA724 and CA199

    Measured: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).

  8. Peripheral blood inflammatory index

    The ratio of lymphocytes to monocytes (LMR) and ratio of Lymphocyte to neutrophil ratio (LNR)

    Measured: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).

  9. Prognostic nutritional index

    Serum albumin level (g/L) +5× total number of peripheral blood lymphocytes (×10 ^ 9 /L)

    Measured: before and after every third cycles of treatment (each cycle is 28 days), assessed up to recurrence and metastasis (up to 3 years after surgery).

  10. Quality of life of the patient

    This will be measured with Quality of Life Questionnaire of Stomach22 (QLQ-STO22). The minimum score is 22 and the maximum is 88. A higher score indicates a poorer quality of life.

    Measured: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.

  11. Evaluation of the patient's symptoms

    This will be measured with M. D. Anderson Symptom Inventory (MDASI-GI) and Postgastrectomy Syndrome Assessment Scale (PGSAS-45). The minimum score of MDASI-GI is 0 and the maximum is 240. The minimum score of PGSAS-45 is 0 and the maximum is 271. A higher score indicates a poorer symptom.

    Measured: Before and after every cycle of treatment (each cycle is 28 days), assessed up to death or 3 years after surgery.

  12. Medication compliance

    The number of cases and percentage were calculated as < 80%, 80-120% and > 120%

    Measured: From randomization to the end of the sixth course of medication （up to 24 weeks）.

  13. Percentage of Participants With Adverse Events

    Percentage of Participants With Adverse Events in different arms.

    Measured: Baseline until disease progression, death, or assessed up to 36 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion31 Jul 2023 (estimated)
  4. Study completion31 Jul 2024 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05229809
Sponsor's protocol ID
CI2021A01802
Status last verified
Oct 2022
First submitted
15 Jan 2022
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The results of the study will be issued to publications through scientific journals and conference reports. The anonymized datasets used and/or analyzed during the current study are available from the sponsor-investigator on reasonable request.

Publications

  • Cao L, Zhu G, Wang X, Kuang Z, Song X, Ma X, Zhu X, Gao R, Li J. Yiqi Wenyang Jiedu prescription for preventing and treating postoperative recurrence and metastasis of gastric cancer: a randomized controlled trial protocol. Front Oncol. 2024 Jul 5;14:1326970. doi: 10.3389/fonc.2024.1326970. eCollection 2024.

    PubMed 39035732

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Yiqi Wenyang Jiedu prescription and Simulation agent of Yiqi Wenyang Jiedu prescription in people with Gastric Carcinoma, run by Jie Li at 6 sites 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 6 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Guanghui Zhu, Doctor (+86 13315714979, zhugh0822@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year disease-free survival rate (time frame: The day of surgery until the second year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05229809, which also lists 1 linked publication.

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 2 Nov 2022.

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