Gastric CancerPhase 4NCT05498766
Effect and Safety of Huaier Granule Versus SOX Regimen in Gastric Cancer Patients
A Phase 4 study testing Huaier granule, Oxaliplatin and Tegafur, Gimeracil and Oteracil Potassium in people with Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Huaier granule, Oxaliplatin and Tegafur, Gimeracil and Oteracil Potassium
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 702 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2024to 1 Nov 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Yanbing Zhou
Wuhan Union Hospital
Wuhan, Hubei, 430022
Kaixiong Tao, PhD, 13507155452, taokaixiong@hust.edu.cn
Yuping Yin, PhD, 15927412321, yinyuping2017@hust.edu.cn
About this study
Official title: Effect and Safety of Huaier Granule Versus SOX Regimen for the Prevention of Recurrence/Metastasis After Radical Surgery for Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, Open-label and Randomised Control Study
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Huaier granule, Oxaliplatin, Tegafur, Gimeracil and Oteracil Potassium
- Keywords
- Huaier granule, Gastric cancer, SOX, Adjuvant therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaier granuleDrug
Also called Z20000109
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.
OxaliplatinDrug
Participants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle.
Tegafur, Gimeracil and Oteracil PotassiumDrug
Participants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest.
| Study group | Role | What they receive |
|---|---|---|
| Huaier group | Experimental | The participants volunteering to take Huaier granule will be assigned to the Huaier group. Receives: Drug: Huaier granule |
| Control group | Active comparator | The participants volunteering to take SOX will be assigned to the control group. Receives: Drug: Oxaliplatin; Drug: Tegafur, Gimeracil and Oteracil Potassium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 36-months follow-up
Secondary outcomes (7)
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.
Measured: up to 12/24-months follow-up
1, 2, 3-year OS rate
The proportion of patients who will be alive within 1/2/3 years after receiving surgery.
Measured: up to 12/24/36-months follow-up
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.
Measured: up to 12/24/36-months follow-up
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.
Measured: up to 12/24/36-months follow-up
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).
Measured: Up to 36 months since the start of treatment
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.
Measured: up to 36-months follow-up
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.
Measured: up to 36-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Jul 2024 (estimated)
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 702 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Principal investigator, kaixiong tao, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- Kaixiong Tao, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498766
- Sponsor's protocol ID
- HE-202205
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2022
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Safety of Huaier Granule Versus SOX Regimen for the Prevention of Recurrence/Metastasis After Radical Surgery for Stage II-III Gastric Cancer Patients: a Prospective, Multi-center, Open-label and Randomised Control Study
- ClinicalTrials.gov ID
- NCT05498766
- Acronym / sponsor ID
- HE-202205
- Conditions
- Gastric Cancer
- Keywords
- Huaier granule, Gastric cancer, SOX, Adjuvant therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 702 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaier group | Experimental | Drug: Huaier granuleThe participants volunteering to take Huaier granule will be assigned to the Huaier group. |
| Control group | Active comparator | Drug: Oxaliplatin, Drug: Tegafur, Gimeracil and Oteracil PotassiumThe participants volunteering to take SOX will be assigned to the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaier granuleAlso: Z20000109Huaier 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. | Drug | Huaier group |
| OxaliplatinParticipants will receive intravenous infusion of 130 mg/m² oxaliplatin on the first day of treatment cycle. | Drug | Control group |
| Tegafur, Gimeracil and Oteracil PotassiumParticipants will receive oral Tegafur, Gimeracil and Oteracil Potassium (40 mg/m², twice a day) for 2 weeks, followed by 1 week of rest. | Drug | Control group |
Primary outcome
3-year DFS rate
Time frame: up to 36-months follow-up
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.
7 secondary outcomes
1, 2-year DFS rate
Time frame: up to 12/24-months follow-up
1, 2, 3-year OS rate
Time frame: up to 12/24/36-months follow-up
1, 2, 3-year local recurrence-free survival rate
Time frame: up to 12/24/36-months follow-up
1, 2, 3-year distant metastasis-free survival rate
Time frame: up to 12/24/36-months follow-up
Quality of life score
Time frame: Up to 36 months since the start of treatment
Incidence and severity of adverse events and serious adverse events
Time frame: up to 36-months follow-up
Incidence and severity of adverse reactions, serious adverse reactions, suspicious and unexpected serious adverse reactions
Time frame: up to 36-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kaixiong Tao, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaier granule, Oxaliplatin and Tegafur, Gimeracil and Oteracil Potassium in people with Gastric Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 2 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaixiong Tao, PhD (13507155452, taokaixiong@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year DFS rate (time frame: up to 36-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2024.