Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Gastric Cancer Patients

Gastric Cancer Clinical Trial

Official title:

Effect and Safety of Adjuvant Huaier Granule Versus Standard Chemotherapy Regimens in Resectable Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, and Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05498766
• Other study ID #: HE-202205
• Status: Recruiting
• Start date: October 12, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: December 2023
• Source: Wuhan Union Hospital, China
• Contact: Kaixiong Tao, PhD
• Phone: 13507155452
• Email: taokaixiong[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective, multi-center, observational study. The purpose of this study is to evaluate the efficacy and safety of Huaier Granule versus standard chemotherapy regimens in the postoperative adjuvant treatment of resectable stage II-III gastric cancer.

Description:

Gastric cancer (GC) is the second most frequently diagnosed cancer and the second leading cause of cancer related deaths in China. China has a higher mortality/incidence ratio (0.845). For stage II-III GC patients, the current standard treatment is D2 gastrectomy followed by adjuvant chemotherapy. Studies showed the 5-year survival rate of early GC is nearly 95%, while the 1-year recurrence and metastasis rate after surgery is about 50%, and the rate of 2-year is as high as 70%.

Although adjuvant chemotherapy can prevent recurrence, it is inevitable to the appearance of toxic and side effects, which seriously affect the prognosis and quality of life.

Traditional Chinese medicine plays a unique role in enhancement of immune function, detoxification, and synergism of chemoradiotherapy. Huaier granule is an extract from a medicinal fungus. Previous studies have shown that Huaier granule can inhibit the proliferation, angiogenesis, metastasis and invasion of cancer cells, and can reverse the resistance of targeted drugs. Previous studies demonstrated Huaier granule is benefit to resistance to recurrence and metastasis, prolongation of patients' survival, and improvement of quality of life.

In this study, about 20 research centers will participate. Total of 828 participants will be divided into two groups (the Huaier group and the control group) at a ratio of 1:1. The Huaier group will receive Huaier granule as postoperative adjuvant therapy, and the control group will receive SOX or XELOX. The planned length of patient recruitment enrolment will be 2 years and the total length of visits be 3 years. After enrollment, participants will be visited every 3 months (window period ± 14 days) until the end of the study or until the patient withdraws from the study for any reason or dies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 828
• Est. completion date: June 30, 2028
• Est. primary completion date: February 10, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years

• Pathologically diagnosed as stage II or III gastric adenocarcinoma (not 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.

Exclusion Criteria:

• Patients had received neoadjuvant therapy.

• Patients allergic to the components of Huaier granules, or avoid to use Huaier granules or use with caution (Huaier Group).

• More than two active primary tumors at the same time.

• Patients have not recovered from surgical complications after radical surgery.

• Expected survival time is less than 3 years.

• 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.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Huaier granule
Huaier granule, oral administration, 20g each time, 3 times a day. Continuous medication until the end of the study, intolerable toxicity, withdrawal from the study for any reason or death, whichever occurs first; or after researcher's judgment, participants will no longer benefit from the treatment. 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 10 days after surgery.
• Oxaliplatin
Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.
• Tegafur, Gimeracil and Oteracil Potassium
Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.
• Capecitabine
Participants will receive oral Capecitabine (1000 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China	LinkDoc Technology (Beijing) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1, 2-year DFS rate	The proportion of patients who do not have recurrence of primary cancer, new gastric cancer, distant metastases (assessed by each investigator), or death from any cause within 1/2 years after receiving surgery.	up to 12/24-months follow-up
Secondary	1, 2, 3-year OS rate	The proportion of patients who will be alive within 1/2/3 years after receiving surgery.	up to 12/24/36-months follow-up
Secondary	1, 2, 3-year local recurrence-free survival rate	The proportion of patients who do not have local recurrence or regional lymph node metastasis from an cause within 1/2/3 years after receiving surgery.	up to 12/24/36-months follow-up
Secondary	1, 2, 3-year distant metastasis-free survival rate	The proportion of patients who do not have distant metastasis from an cause within 1/2/3 years after receiving surgery.	up to 12/24/36-months follow-up
Secondary	Quality of life score	The patients will evaluated by the Short-Form 36 (SF-36) Health Survey (Chinese version), which is a 36-item questionnaire measures health on 8 multi-item dimensions. Scores are computed for each dimension by adding the recorded item responses together and transforming the results onto a scale from 0 (worst health on scale) to 100 (best health on scale).	Up to 36 months since the start of treatment
Secondary	Incidence and severity of adverse events and serious adverse events	The incidence of adverse events and serious adverse events (referring to CTCAE 5.0 ) will be analyzed.	up to 36-months follow-up
Secondary	Incidence and severity of adverse reactions, serious adverse reactions, suspicious and unexpected serious adverse reactions	The incidence of ADR, SADR and SUSAR (referring to CTCAE 5.0 ) will be analyzed.	up to 36-months follow-up