Trial Title:
Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients
NCT ID:
NCT05498766
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Oxaliplatin
Tegafur
Conditions: Keywords:
Huaier granule
Gastric cancer
SOX
Adjuvant therapy
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Huaier granule
Description:
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.
Arm group label:
Huaier group
Other name:
Z20000109
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day
of treatment cycle.
Arm group label:
Control group
Intervention type:
Drug
Intervention name:
Tegafur, Gimeracil and Oteracil Potassium
Description:
Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice
a day) for 2 weeks, followed by 1 week of rest.
Arm group label:
Control group
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.
Detailed 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 30 research centers will participate. Total of 702 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 regimen. 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 12 weeks (window period ± 14 days) until the end of
the study or until the patient withdraws from the study for any reason or dies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 18-75 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430022
Country:
China
Contact:
Last name:
Kaixiong Tao, PhD
Phone:
13507155452
Email:
taokaixiong@hust.edu.cn
Contact backup:
Last name:
Yuping Yin, PhD
Phone:
15927412321
Email:
yinyuping2017@hust.edu.cn
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Contact:
Last name:
Yanbing Zhou
Start date:
July 1, 2024
Completion date:
November 1, 2029
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
LinkDoc Technology (Beijing) Co. Ltd.
Agency class:
Industry
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05498766
