Gastric/Gastroesophageal Junction AdenocarcinomaPhase 2NCT06774222
A Study of Fruquintinib Plus Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer With Poor TRG
A Phase 2 study testing Fruquintinib in people with Gastric/Gastroesophageal Junction Adenocarcinoma, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric/Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2023to 31 Dec 2026
- Phase
- Phase 2
- 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
- Fully understand the study and voluntarily sign the informed consent form;
- Age between 18 and 75 years;
- Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
- Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
- R0 resection after neoadjuvant chemotherapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
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- Life expectancy of at least 2 years;
- No prior anti-cancer treatment received;
- Good compliance and cooperation with follow-up.
Who cannot join
- Inability to comply with the study protocol or procedures;
- History of prior gastric cancer surgery;
- Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
- Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- Known HER2-positive patients;
- Uncontrolled hypertension despite medication prior to enrollment;
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- Poorly controlled diabetes despite medication prior to enrollment;
- Urine routine indicating proteinuria ≥2+, and a 24-hour urine protein quantification >1.0g;
- Presence of conditions requiring intervention such as bleeding, perforation, or obstruction prior to enrollment;
- Patients deemed ineligible for this study by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.
Read the detailed description
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .
- Being tested
- Fruquintinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called HMPL-013
Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Fruquintinib Combined with Standard Chemotherapy Receives: Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year recurrence-free survival rate
Percentage of recurrence-free patients within 3 years of surgery
Measured: Three years after surgery
Secondary outcomes (2)
Overall survival
From the start of treatment to the date of death from any cause
Measured: OS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years"
AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Patients' blood and non-blood abnormal values or conditions were collected according to the frequency of visits per cycle and recorded for evaluation using CTCAE5.0 criteria
Measured: from the first drug administration to within 30 days for the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start12 Sep 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric/Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fei Ma, M.D., Principal investigator, Working relationship
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774222
- Sponsor's protocol ID
- 2022-421
- Status last verified
- Nov 2024
- First submitted
- 12 Dec 2024
- Last updated
- 14 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm, Single-Center Study of Fruquintinib Combined With Standard Chemotherapy for Postoperative Treatment of HER2-Negative Gastric Cancer Patients With Poor Tumor Regression Grade.
- ClinicalTrials.gov ID
- NCT06774222
- Acronym / sponsor ID
- 2022-421
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients.
Detailed description
Given that a significant proportion of locally advanced gastric cancer patients still die from tumor recurrence after surgery, with long-term therapeutic outcomes stagnating and difficult to further improve, especially for patients with poor tumor regression grade (TRG) after surgery, this study aims to explore a new model of adjuvant therapy by conducting research on the use of Fruquintinib in combination with standard chemotherapy for postoperative treatment of HER2-negative gastric cancer patients with poor TRG, in order to bring greater survival benefits to patients. The primary endpoint of this study is to evaluate the recurrence-free survival (RFS) in patients with poor TRG after neoadjuvant chemotherapy for gastric cancer who receive adjuvant therapy with Fruquintinib combined with standard chemotherapy postoperatively. Secondary endpoints include overall survival (OS) and safety .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: FruquintinibFruquintinib Combined with Standard Chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fully understand the study and voluntarily sign the informed consent form;
- Age between 18 and 75 years;
- Histologically confirmed resectable or potentially resectable locally advanced gastric/gastroesophageal junction adenocarcinoma;
- Tumor Regression Grade (TRG) 2 or 3 after preoperative adjuvant therapy;
- R0 resection after neoadjuvant chemotherapy;
Key exclusion criteria (10 listed)
- Inability to comply with the study protocol or procedures;
- History of prior gastric cancer surgery;
- Contraindications to surgical treatment and chemotherapy or physical condition and organ function that do not allow for major abdominal surgery;
- Distant metastasis to organs other than the liver, such as lung, brain, and bone;
- Known HER2-positive patients;
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 |
|---|---|---|
| FruquintinibAlso: HMPL-013Fruquinitinib: Take 4 mg QD for 2 weeks and stop for 1 week, every 3 weeks for a cycle; Standard chemotherapy: The selection of drugs is recommended by the 2024CSCO Guidelines for the Diagnosis and Treatment of Gastric Cancer, including SOX, XLOX or S-1, and the treatment cycle is one every 3 weeks | Drug | Experimental group |
Primary outcome
3-year recurrence-free survival rate
Time frame: Three years after surgery
Percentage of recurrence-free patients within 3 years of surgery
2 secondary outcomes
Overall survival
Time frame: OS is the time interval from the start of treatment to death due to any reason or lost of follow-up，whichever came first, assessed up to 3 years"
AEs-Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: from the first drug administration to within 30 days for the last dose
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 14 Jan 2025.
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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.
Fei Ma, M.D. principal investigator
Working relationship
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fruquintinib in people with Gastric/Gastroesophageal Junction Adenocarcinoma, run by Henan Cancer Hospital at 1 site 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 9 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: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Fei Ma, M.D. (+8613703923592, mafeizzu@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year recurrence-free survival rate (time frame: Three years after surgery). 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 14 Jan 2025.