Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients

NCT05498766 | Not Yet Recruiting Phase 4

• 1 other identifier: HE-202205
• Study Type: interventional
• Target: 702
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective, multi-center, open-label, randomised controlled study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus SOX regimen in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.

Conditions

Gastric Cancer

Keywords

Huaier granule; Gastric cancer; SOX; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• 3-year DFS rate

  The proportion of patients who does not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 3 years after receiving surgery.

  up to 36-months follow-up

Secondary Outcomes (7)

• 1, 2-year DFS rate

  up to 12/24-months follow-up

• 1, 2, 3-year OS rate

  up to 12/24/36-months follow-up

• 1, 2, 3-year local recurrence-free survival rate

  up to 12/24/36-months follow-up

• 1, 2, 3-year distant metastasis-free survival rate

  up to 12/24/36-months follow-up

• Quality of life score

  Up to 36 months since the start of treatment

Study Arms (2)

Huaier group

EXPERIMENTAL

The participants volunteering to take Huaier granule will be assigned to the Huaier group.

Drug: Huaier granule

Control group

ACTIVE COMPARATOR

The participants volunteering to take SOX will be assigned to the control group.

Drug: Oxaliplatin; Drug: Tegafur, Gimeracil and Oteracil Potassium

Interventions

Huaier granule DRUG

Huaier granule, oral administration, 10g each time, 3 times a day. Continuous medication until disease progression, the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, or until the researcher determines that the participants will no longer benefit, whichever occurs first. After disease progression, whether to continue the medication or not should be determined by the researcher and participant together. Participants will start taking Huaier granule within 1 to 3 weeks after surgery.

Also known as: Z20000109

Huaier group

Oxaliplatin DRUG

Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.

Control group

Tegafur, Gimeracil and Oteracil Potassium DRUG

Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• Pathologically diagnosed as stage II or III gastric adenocarcinoma (including gastroesophageal junction).
• Receiving radical surgery (R0, D2 resection, more than 16 lymph nodes should be detected) for gastric adenocarcinoma within 2 months prior to enrollment, and not receiving adjuvant treatment.
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
• Patients are volunteers, have signed informed consent, and agree to cooperate with investigators in data collection.

You may not qualify if:

• Patients had received neoadjuvant therapy.
• Patients who have received or plan to receive targeted therapy and/or immunotherapy。
• Patients allergic to the components of Huaier granules, or avoid to use Huaier granules or use with caution.
• More than two active primary tumors at the same time.
• Patients have not recovered from surgical complications after radical surgery.
• Patients received other Chinese patent medicine with anti-tumor effects.(including but not limited to Huaier Granule, Fufangbanmao Capsule, Huachansu Capsule, Kangai Injection, Pingxiao Table) in the past 1 month.
• Not able to take medication orally cause by difficulty in swallowing, complete or incomplete gastrointestinal obstruction, active bleeding from the gastrointestinal tract, perforation, etc.
• Pregnant or lactating women or women prepare for pregnancy.
• Serious concomitant infection disease.
• Patients with severe psychiatric illness or otherwise diseases are unsuitable for this study according to the judgment by investigators.
• Patients with combined immune disease and receiving immunosuppressive therapy.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead
• LinkDoc Technology (Beijing) Co. Ltd.: collaborator

Study Sites (2)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Oxaliplatin; Tegafur; gimeracil; potassium oxonate

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kaixiong Tao, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaixiong Tao, PhD

CONTACT

13507155452; taokaixiong@hust.edu.cn

Yuping Yin, PhD

CONTACT

15927412321; yinyuping2017@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 12, 2022
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)